[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Centre Leon Berard\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":712},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,48,0,25,[9,47,75,106,136,168,197,225,256,277,303,330,352,378,408,434,474,506,526,556,578,600,627,651,680],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100645176","phase-1-safety-and-efficacy-of-nivolumab-and-imiquimod-combination-in-vulvar-squamous-cell-carcinoma-patients-100645176",false,"NCT07679841","Safety and Efficacy of Nivolumab and Imiquimod Combination in Vulvar Squamous Cell Carcinoma Patients","A Multicentre, Single Arm, Phase 1\u002F2 Study, Aiming to Assess the Safety and Efficacy of Nivolumab and Imiquimod Combination in Vulvar Squamous Cell Carcinoma Patients","COLOMBE","Inclusion Criteria:\n\nI1. Female patient ≥ 18 years of age on day of signing informed consent.\n\nI2. Histologically confirmed primary VSCC, with all of the following characteristics:\n\n* At least 1 lesion that can be measured in at least 1 dimension with ≥ 10 mm in largest diameter\n* Clinically stage FIGO I-III (2021 FIGO staging)\n* Eligible for primary tumour surgery\n* Surgical complexity due to either bulky tumors \\> 4 cm OR multifocal tumor (defined as the presence of two or more foci of cancer on the vulva), the largest lesion must be ≥ 10 mm and all lesions ≥ 10 mm are designated as \"target\" lesion(s) for all subsequent tumor evaluations OR any tumor for which a surgical excision would have anatomical or functional consequences deemed significant by the treating surgeon\n\nI3. Availability of a representative formalin-fixed paraffin-embedded (FFPE) sample of the primary tumor tissue (biopsy) with an associated pathology report. This tumor sample must meet the following quality\u002Fquantity control criteria: ≥30 % of tumor cells and a tumor surface area ≥ 5mm2\n\nI4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2\n\nI5. Patients with adequate organ function:\n\n* Absolute Neutrophil Count (ANC) ≥ 1 10\\^9\u002FL\n* Platelets ≥ 100 10\\^9\u002FL (without transfusion for platelets within 7 days)\n* Hemoglobin ≥ 9 g\u002FdL\n* Creatinine clearance according to CKD-EPI ≥ 30 mL\u002Fmin\n* Serum total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3 x ULN is acceptable)\n* AST and ALT ≤ 3 x ULN\n\nI6. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to C1D1 and must agree to use effective forms of contraception from the time of the negative pregnancy test up to 5 months after the last dose of nivolumab.\n\nI7. Patient should understand, sign, and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.\n\nI8. Patients must be covered by a medical insurance.\n\nExclusion Criteria:\n\nE1. Patients participating in another clinical trial with therapeutic intent.\n\nE2. Patients previously treated with any anti-cancer treatment including anti-PD-1, anti-PDL1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (e.g., CTLA-4, OX 40, CD37).\n\nE3. Patients not respecting the minimal washout period or receiving or anticipation of need during the study of the following medications\u002Fprocedure:\n\n* Major surgery: 2 weeks\n* Live vaccines: 4 weeks\n* Systemic corticosteroids (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy: 1 week\n\nE4. Patients with known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\nNote: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin on a location other than the vulva, or carcinoma in situ (e.g. of the breast, cervix or bladder) that have undergone potentially curative therapy are not excluded.\n\nE5. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n\nE6. Patients with evidence of significant uncontrolled infection or concomitant disease, or psychiatric illness\u002Fsocial situations that could affect compliance with the protocol or interpretation of results.\n\nE7. Patients with prior organ or bone marrow transplant.\n\nE8. Patients with known active hepatitis B, C, or HIV infection or any active infection requiring systemic therapy.\n\nE9. Patients with known or suspected active autoimmune disease. Note: Patients with skin disorders (such as vitiligo, psoriasis or alopecia), type I diabetes mellitus, hypothyroidism only requiring hormone replacement or conditions not expected to recur in the absence of an external trigger are eligible.\n\nE10. Pregnant or breastfeeding women.","FEMALE","18 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","COLOMBE is a multicenter, single arm, phase 1\u002F2 trial designed to evaluate the safety and efficacy of imiquimod cream with IV low dose nivolumab in primary resectable vulvar squamous cell carcinoma patients prior to surgery, leveraging the preoperative \"window of opportunity\" period, an unavoidable interval due to surgical scheduling.",[29],"Vulvar Squamous Cell Carcinoma",[31,32,33],"vulvar squamous cell carcinoma","nivolumab","imiquimod","NOT_YET_RECRUITING","2026-06-25",{"date":37,"type":38},"2026-07-01","ACTUAL",{"date":40,"type":22},"2026-09",{"date":42,"type":22},"2029-09",{"name":44,"class":45},"Centre Leon Berard","OTHER",3,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":55,"minAge":19,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100542694","phase-3-combination-of-immune-checkpoint-in-locally-advanced-or-metastatic-msidmmr-esogastric-adenocarcinomas-100542694","NCT06346197","Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI\u002FdMMR Esogastric Adenocarcinomas","A Multicenter, Randomised, Comparative, Open-label Phase III Aiming to Compare the Survival of Patients With Locally Advanced or Metastatic MSI\u002FdMMR Esogastric Adenocarcinomas Treated by a Combination of Immune Checkpoint Inhibitors (Botensilimab + Balstilimab) Versus the Standard of Care (FOLFOX\u002FXELOX + Nivolumab)","CIME","Inclusion Criteria:\n\n* Male or female patient ≥18 years of age at time of informed consent form signature.\n* Patient with MSI-H\u002FdMMR, HER2 negativeadvanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5. Note :The claudin 18.2 status must be known and documented before inclusion.\n* Patient to be treated with a first line therapy for locally advanced\u002Fmetastatic disease.\n* No prior treatment with chemotherapy for locally advanced\u002Fmetastatic disease.\n\n  o Note - adjuvant or neoadjuvant chemotherapy is allowed providing that 6 months have relapsed between completion of adjuvant chemotherapy and recurrence.\n* Measurable disease (outside any previous irradiated field within the past 6 months) defined as at least one unidimensional lesion that can be accurately measured as ≥ 10 mm with CT scan according to RECIST V1.1 (Appendix 01).\n\n  * Note: Lesions intended to be biopsied should not be defined as target lesions.\n  * Note: previously irradiated lesions can be selected as target lesion only if recurrence\u002FPD is documented after RT.\n* Patient with PS ECOG 0 or 1 (Appendix 02).\n* Adequate hematologic and end-organ function, defined by the following laboratory test results:\n\nAbsolute neutrophil count ≥ 1.5 109\u002FL (without growth factor support within 14 d) Platelets ≥ 100 109\u002FL (without transfusion for platelets within 7 d) Hemoglobin ≥ 9 g\u002FdL (without transfusion within 7 d) Creatinine clearance according to CKD-EPI ≥ 30 mL\u002Fmin\u002F1.73 m2 Serum total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3 x ULN is acceptable) ASAT and ALAT ≤ 3 x ULN (or up to 5 x ULN in case of liver metastasis or hepatic infiltration)\n\n* Availability of a representative formalin-fixed paraffin-embedded (FFPE) sample of the primary or metastatic tumor tissue (resection or biopsy) with an associated pathology report must be available. This tumor sample must meet the following quality\u002Fquantity control criteria: ≥30 % of tumor cells and a tumor surface area ≥ 5mm2 or biopsiable disease (see next inclusion criteria).\n* Tumor lesion visible by medical imaging and accessible to repeatable percutaneous or endoscopic sampling that permits core needle biopsy without unacceptable risk of a significant procedural complications, and suitable for retrieval of a minimum of 4 cores with a needle minimum diameter :16-gauge.\n\n  * Note 1: Fine needle aspirates, bone biopsies do not satisfy the requirement for tumor tissue.\n  * Note 2: Tumor lesions used for biopsy should not be lesions used as RECIST 1.1 target lesions unless there are no other lesions suitable for biopsy. If a RECIST target lesion is used for biopsy, the lesion must be ≥ 2 cm in longest diameter.\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at the Screening Visit (within 72 hours of first dose of study drugs) and must agree to use highly effective contraceptive measures starting with the Screening Visit through\n\n  * 9 months after the end of the treatment with oxaliplatin\n  * 6 months after the end of the treatment with fluorouracil\n  * 5 months after the end of the treatment with nivolumab or botensilimab or Balstilimab\n  * 6 months for capecitabine\n\n    * Highly effective contraception is defined in Appendix 03.\n\nNote Non-childbearing potential is defined as:\n\n1. ≥ 50 years of age and has not had menses for greater than 1 year.\n2. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation.\n3. Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation.\n\n   * Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 6 months after the end of the treatment with oxaliplatine or 3 months after the last dose for other study treatments is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n   * Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and should be able and willing to comply with study visits and procedures as per protocol.\n   * Patients must be covered by a medical insurance.\n\nExclusion Criteria:\n\n* Oesogastric cancer eligible to treatment with curative intent\n* Patients previously treated by anti-PD-1, anti-PD-L1, or anti-CTLA-4 or any other immunotherapy\n* Patients with surgery or radiotherapy within less than 4 weeks before C1D1\n* Patients with persistent AE Grade \\>1 related to previous anti-cancer treatment, except alopecia (all grades), laboratory value according to criteria I7.\n* Patients with: hypokalemia, hypomagnesemia, hypocalcemia less than normal\n* Patients with known prolongation QT\u002FQTc interval i.e. QT\u002FQTc interval longer than 450 msec for men and longer than 470 msec for women according to the inclusion ECG.\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.\n\nNote: Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:\n\n* Measurable disease, per RECIST v1.1, must be present outside the CNS.\n* The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.\n* Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).\n* There is no evidence of interim progression between completion of CNS-directed therapy and initiation of study treatment.\n* The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, neurosurgical resection within 21 days prior to initiation of study treatment.\n* The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted. A minimal wash-out period of 10days for corticosteroids is required.\n\n  * Patients with other malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints (basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer), or with no evidence of disease for ≥ 2 years.\n  * Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n  * of ILD or non-infectious pneumonitis requiring glucocorticoids.\n  * History of allogeneic organ transplant.\n  * Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n  * Patient with peripheral sensory neuropathy with functional impairment.\n  * Patients with clinically significant active heart disease or myocardial infarction within 6 months, history of uncontrolled or symptomatic cardiac disease.\n  * Patient with recent (within 7d before C1D1) or concomitant treatment with brivudine.\n  * Patient with complete absence of dihydropyrimidine dehydrogenase (DPD) activity (blood uracil level ≥ 150 ng\u002FmL) or partial deficit in DPD (i.e. blood uracil level between ≥ 16 ng\u002Fml and \\\u003C 150 ng\u002FmL)\n  * Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.\n  * Patient with Live vaccines injection within 4 weeks before C1D1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed.\n  * Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).\n  * History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n  * Patients with documented:\n* Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) unless their HBV is stably controlled on nucleoside analogs (eg entecavir or tenofovir) which will be continued for the duration of the study. Note: Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to C1D1.\n* Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or\n* HIV infection\n\n  * Prior organ or bone marrow transplant.\n  * Pregnant or lactating women.","ALL",{"count":57,"type":22},132,[59],"PHASE3","CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H\u002FdMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX\u002FXELOX + nivolumab : standard arm).",[62,63,64,65],"Gastric Cancer","MSI-H","Metastatic Cancer","Advanced Cancer","RECRUITING","2026-06-23",{"date":35,"type":38},{"date":70,"type":38},"2025-12-08",{"date":72,"type":22},"2028-05-15",{"name":44,"class":45},7,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":55,"minAge":19,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100512029","pasca-mm-study-impact-of-the-pasca-parcours-de-sant-au-cours-du-cancer-program-on-complications-associated-with-multiple-myeloma-andor-its-treatments-in-the-context-of-a-first-hematopoietic-stem-cell-autograft-in-adults-aged-18-to-70-100512029","NCT05947136","PASCA-MM Study. Impact of the PASCA (PArcours de Santé au Cours du CAncer) Program on Complications Associated With Multiple Myeloma and\u002For Its Treatments in the Context of a First Hematopoietic Stem Cell Autograft, in Adults Aged 18 to 70.","PASCA -MM","Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 70 years old.\n2. Patient treated in an investigation center.\n3. Symptomatic multiple myeloma eligible for autologous hematopoietic stem cell transplantation (HSCT).\n4. In complete response, complete response, very good complete response, or partial before HSCT.\n5. First induction-type treatment (Isa-KRD\u002Fdara-VRD\u002Fdara-VTD\u002FVRD\u002FVTD\u002Fdara-VRD), intensification therapy with melphalan, HSCT, consolidation, maintenance including at least one drug immunomodulator.\n6. ECOG performance status WHO ≤ 2.\n7. No history or coexistence of other primary cancer apart from basal cell cancer cutaneous\n8. Able to understand, read and write French.\n9. Having signed and dated the informed consent.\n\nExclusion Criteria:\n\n1. Unable to be monitored for medical, social, family, geographical or psychological, throughout the duration of the study.\n2. Deprived of liberty by court or administrative decision.\n3. Not affiliated with a health insurance plan.\n4. Not having declared an attending physician.\n5. Not domiciled in the Auvergne-Rhône-Alpes region or in the Saône-et-Loire department.\n6. Not available and\u002For not willing to participate in the project for the entire duration of the study.\n7. Pregnant women, breastfeeding women, people in emergency situations, people incapable of personally giving their consent including adults under guardianship","70 Years",{"count":84,"type":22},204,[86],"NA","This is a prospective, multicentre, phase III, randomised, controlled intervention study.\n\nTwo groups of patients with equal numbers will be studied and each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1).\n\nEach patient will be allocated to one of the two groups described below by randomisation (ratio 1:1).\n\n\\- PASCA interventional group\n\nFor both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective), a specific and proactive referral will be made systematically after each screening assessment, depending on the level of risk, estimated according to decision trees (management guide) and through the dedicated PASCA network of healthcare professionals, in order to initiate early treatment and follow-up if necessary.\n\n\\- Control group\n\nFor the 7 complications of interest (primary objective) as well as for the 13 complications (secondary objective): all the data from each identification check-up will be sent to the onco-haematological transmitted to the referring onco-haematologists, so that they can initiate their own management.\n\n=\\> For all patients, regardless of group\n\nAll patients will receive four screening assessments covering the 7 complications of interest and 13 secondary complications:\n\n* Visit No.1 (T1), 1-2 months after the autologous haematopoietic stem cell transplantation (aHSCT), corresponding to the patient's visit to his or her Multiple Myeloma (MM) monitoring consultation and\u002For the start of his or her consolidation treatment.\n* Visit No.2 (T2), 4 months after aHSCT, corresponding to a patient's visit for the end of consolidation treatment;\n* Visit No.3 (T3), 14 months after the last aHSCT, corresponding to a visit by the patient during his or her maintenance treatment;\n* Visit No.4 (T4), 24 months after the last aHSCT, corresponding to a visit by the patient for a MM monitoring consultation.",[89,90],"Multiple Myeloma","Complication",[89,92,93,94,95,96],"Complications","Detection","Intervention","Autologous stem cell transplant","Randomized controlled trials","2026-06-09",{"date":99,"type":38},"2026-06-11",{"date":101,"type":38},"2024-01-19",{"date":103,"type":22},"2029-09-14",{"name":44,"class":45},6,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":55,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},"100643202","canut-junior--assessment-of-sensory-abilities-and-eating-behavior-in-pediatric-oncology-a-feasibility-study-100643202","NCT07632560","CANUT Junior : Assessment of Sensory Abilities and Eating Behavior in Pediatric Oncology: a Feasibility Study","CANUT Junior","Inclusion Criteria:\n\n* Patients treated at a pediatric oncology-hematology center, with an initial diagnosis of a solid or hematological tumor, aged 7 to 17 years inclusive.\n* Patients with functional oral feeding\n* Parent\u002Fguardian who has signed the informed consent form and patient who has not expressed refusal\n* Patients affiliated with the social security system\n* French-speaking patients\n* Validated indication for systematic oncological treatment\n\nExclusion Criteria:\n\n* Individuals with a known food allergy\u002Fintolerance to the prototypes being studied (does not apply to patients on a protected diet)\n* Individuals who have undergone surgery on the tongue\n* Patients for whom other types of cancer treatment are planned during the study period (e.g., radiation therapy)\n* Patients with dental conditions\n* Patients who have relapsed","7 Years","17 Years",{"count":116,"type":22},30,[86],"Cancer treatments in children are very intense and often cause side effects such as nausea, vomiting, loss of appetite, and changes in taste and smell. These sensory alterations can impact eating habits, but they are still poorly understood in children. The study aims to assess whether it is feasible to measure these sensory changes (taste, smell, salivation, and food preferences) in children and adolescents undergoing cancer treatment.\n\nThis study is a feasibility study with 30 patients aged 7 to 17 years, treated at the Pediatric Hematology and Oncology Institute (IHOPE) in Lyon. Sensory tests and questionnaires to evaluate the perceptions, oral health, eating habits, nutritional status, and quality of life are used.\n\nThe inclusion was initially planned at diagnosis, before any administration of chemotherapy. However, the study quickly encountered a recruitment problem due to the emotional impact and medical burden of this initial period of care (study offered to 11 families over a period of 5 months, 3 patients included). An amendment to the protocol was therefore made to be able to modify the inclusion period after the completion of chemotherapy. This modification was implemented on May 15, 2025, and allowed the inclusion of two new patients, making a total of 5 patients. Of these 5 patients, two completed all the tests during V0 and V1, two completed V0 but not V1, one did not complete any of the visits.\n\nThis feasibility phase will help determine whether the tools are suitable and well accepted. The results will be used to design a larger study aimed at better understanding how taste and smell alterations influence the eating behaviors of young patients during cancer treatment. Recruitment will continue for six more months in order to reach the target number of participants.",[120,121],"Pediatric Hematologic Malignancies","Pediatric Oncology",[123,124,125,126],"taste alteration","sensory alteration","chemotherapy","pediatrics","2026-06-02",{"date":129,"type":38},"2026-06-08",{"date":131,"type":38},"2024-12-13",{"date":133,"type":22},"2026-06",{"name":44,"class":45},1,{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":55,"minAge":144,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":153,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100611660","phase-1-combination-of-tarlatamab-and-temozolomide-in-patients-with-central-nervous-system-tumors-100611660","NCT07243470","Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors","A Multicenter, Open-label Phase I\u002FII Trial Aiming to Assess the Safety and Clinical Activity of Tarlatamab in Combination With Metronomic Temozolomide in Adolescents and Adults' Patients With High Grade Brain Tumors","TARLATEM","Inclusion Criteria:\n\nI1. Patients aged ≥ 12 years old at time of inform consent signature.\n\nI2. Histologically proven diagnosis of central nervous system (CNS) malignant tumor: IDH-mutant high-grade glioma, other high-grade glioma, or other high-grade CNS tumors.\n\nI3. Tumors expressing DLL3 based on IHC staining performed on archival tumor sample i.e. at least 1+ on IHC \\[patient with no tumor expression of DLL3 are not eligible\\].\n\nNote- This pre-screening by IHC should be optimally initiated during an ongoing line of treatment i.e. before documented progression. The ICF1 must be signed before to initiate this pre-screening.\n\nI4. Confirmed progressive or refractory disease after at least one line of standard therapy containing radiotherapy and for which no further effective standard therapy exists.\n\nI5. Evaluable or measurable disease as per iRANO criteria.\n\nI6. Performance status (See Appendix 01):\n\n1. Karnofsky PS for pediatric patients ≥16 years of age ≥ 70%;\n2. Lansky PS for patients between 12 and 15y: ≥ 70%;\n3. PS ECOG for adult patients: 0 or 1.\n\nI7. Life expectancy ≥ 3 months.\n\nI8. Adequate end organ function according to laboratory values defined below :\n\nHematologic criteria :\n\n* Peripheral absolute neutrophil count (ANC) ≥1.5 G\u002FL (without growth factor support within 7 days)\n* Platelet count ≥ 100 G\u002FL (unsupported for \\> 7 days)\n* Hemoglobin ≥ 9.0 g\u002FdL (unsupported for \\> 7 days)\n\nRenal and hepatic function :\n\n* Creatinine\n* Adult patient: Creatinine clearance as per CKD-EPI \\> 30 mL\u002Fmin\u002F1.73 m²\n* Pediatric patients: Creatinine \\\u003C1.5 ULN for age or an estimated glomerular filtration rate (GFR) \\> 60 mL\u002Fmin\u002F1.73m2 GFR based on the Schwartz equation (Mian and Schwartz 2017) or as per institutional guidelines\n* Total bilirubin ≤1.5 x ULN (≤ 3.0 × ULN for patients with Gilbert's syndrome)\n* Alanine aminotransferase (ALAT) ≤ 3 x ULN; aspartate aminotransferase (ASAT) ≤ 3 x ULN Coagulation function : Prothrombin time (PT)\u002Finternational normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x ULN. Patients on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enrol after discussion with the Sponsor.\n\nI9. Adequate cardiac function defined by Left ventricular ejection fraction (LVEF) ≥50% at baseline.\n\nI10. Adequate pulmonary function as per investigator judgment and no clinically significant pleural effusion. Pleural effusion managed with indwelling pleural catheter (e.g, PleurX) are allowed.\n\nI11. Availability of a representative formalin-fixed paraffin-embedded (FFPE) sample of tumor tissue (resection or biopsy, archival) with an associated pathology report must be available. This tumor sample must meet the following quality\u002Fquantity control criteria: ≥30 % of tumor cells.\n\nI12. Patients must have discontinued all previous anti-cancer treatments (approved or investigational) for CNS treatment with respect of wash-out period at time of C1D1 as shown below:\n\n* Cytotoxic and myelosuppressive chemotherapy : ≥21 days (or ≥42 days if prior nitrosourea)\n* Metronomic chemotherapy regimen : ≥21 days or ≥5 half-lives of the treatment with the longest half-life (whichever is shorter)\n* Targeted agent : ≥21 days or ≥5 half-lives (whichever is shorter)\n* Cellular therapy : ≥42 days for any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells) agent\n* Antibody therapy : ≥21 days after the last infusion except for bevacizumab for which a wash out period of 3 months is requested\n* Radiotherapy :\n* ≥14 days since small port radiation therapy (i.e. local palliative)\n* ≥84 days since large-field radiation therapy (i.e. TBI, craniospinal, whole abdominal, total lung, ≥50% or greater pelvic radiation, ≥50% marrow space)\n* ≥42 days for other substantial bone marrow radiation\n* Surgery : Major surgery ≥ 21 days. Gastrostomy, ventriculo-peritoneal shunt, endoscopic ventriculostomy, tumor biopsy and insertion of central venous access devices are not considered major surgery, but for these procedures, a 48-hour interval must be maintained before C1D1\n\nI13. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior C1D1 and must agree to use highly effective contraceptive measures starting with the Screening Visit through 6 months after the last dose of study drugs and to not breastfeed during this period. Highly effective contraception is defined in Appendix 02.\n\nI14. Sexually active male must agree to use adequate and appropriate contraception while on study drugs and for 6 months after stopping the study drugs.\n\nI15. Ability to understand and sign informed consent and willingness to comply with the study procedures before study entry and written informed consent from parents\u002Flegal representative, patient, and age-appropriate assent before any study-specific screening procedures are conducted according to local, regional or national guidelines.\n\nI16. Covered by a medical insurance.\n\nExclusion Criteria:\n\nE1. Diagnosis of non-CNS tumor.\n\nE2. Diagnosis of diffuse intrinsic pontine glioma.\n\nE3. Current treatment with bevacizumab.\n\nE4. Prior treatment with a DLL3-directed therapy. Note: Prior treatment with TMZ is not an exclusion criteria.\n\nE5. Neurologically unstable or require increasing doses of corticosteroids during the 7 days before C1D1 or local CNS-directed therapy to control their CNS disease. Note: Patients on low doses of corticosteroids (\\\u003C 0.25mg\u002Fkg\u002Fd of prednisolone or equivalent) during the 7 days prior to receiving study drugs are eligible.\n\nE6. Evidence of Grade \\> 1 recent CNS hemorrhage on the baseline MRI scan.\n\nE7. Bulky tumor on imaging defined as:\n\ni. Tumor with any evidence of uncial herniation or severe midline shift ii. Tumor with diameter of \\> 6 cm in one dimension on contrast-enhanced MRI iii. Tumor that in the opinion of the investigator shows significant mass effect.\n\nE8. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome)\n\nE9. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to C1D1.\n\nE10. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 6 months of C1D1).\n\nE11. Other malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints (basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer), or with no evidence of disease for ≥ 2 years.\n\nE12.History of hypophysitis or pituitary dysfunction.\n\nE13.History of severe allergic or other hypersensitivity reactions to\n\n* chimeric or humanized antibodies or fusion proteins,\n* biopharmaceuticals produced in Chinese hamster ovary cells,\n* or any component of the tarlatamab formulation.\n\nE14.Known hypersensitivity to any study drug or component of the formulation or to dacarbazine or TMZ.\n\nE15.Acute and ongoing toxicities from previous therapy that have not resolved to Grade ≤1, except for alopecia, neuropathy, ototoxicity and lab values presented in inclusion criteria.\n\nE16.Arterial thrombosis or a history of pulmonary embolism who need anticoagulants.\n\nE17.Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n\nE18.Recurrent pneumonitis (grade 2 or higher) or grade≥3 immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents.\n\nE19. Live vaccines injection within 4 weeks before C1D1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed.\n\nE20. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).\n\nE21. Documentation of:\n\n▪ Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) unless their HBV is stably controlled on nucleoside analogs (eg entecavir or tenofovir) which will be continued for the duration of the study.\n\nNote: Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to C1D1.\n\n* Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or\n* HIV infection\n\nE22. Prior organ or bone marrow transplant\n\nE23. History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n\nE24. Pregnant or breastfeeding women.","12 Years",{"count":146,"type":22},70,[25,26],"This clinical trial is a 2-phase trial designed to evaluate the safety of tarlatamab in combination with a fixed dose of metronomic temozolomide in adolescents and adults with CNS tumors (stratified into two age-based cohorts), and to assess the clinical activity of this therapeutic strategy in three parallel, histology-defined cohorts (IDH-mutant glioma, other gliomas, and other CNS tumors). A pre-screening to detect DLL3 expression by IHC on archival tumor sample must be performed before the therapeutic part. Only patients with DLL3 positive tumor on IHC can be enrolled in the therapeutic part. This pre-screening must be optimally performed during the ongoing treatment line i.e. before documented progression to not delay treatment starts at time of progression. Tumor samples (surgery or biopsy specimen) will be sent to a central lab for IHC testing.",[150,151,152],"Glioma","CNS Tumor, Adult","CNS Tumor, Childhood",[154,155,156,157,158],"temozolomide","tarlatamab","phase 1\u002F2","RP2D","glioma","2026-05-26",{"date":161,"type":38},"2026-05-27",{"date":163,"type":38},"2025-11-04",{"date":165,"type":22},"2030-10",{"name":44,"class":45},12,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":55,"minAge":19,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":23,"phases":178,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},"100611661","study-of-the-relationship-between-the-pharmacokinetics-pk-and-pharmacodynamics-of-venetoclax-in-patients-with-acute-myeloblastic-leukemia-100611661","NCT07243483","Study of the Relationship Between the Pharmacokinetics (PK) and Pharmacodynamics of Venetoclax in Patients With Acute Myeloblastic Leukemia","Prospective, Multicenter, Clinical-biological Cohort Study to Assess Pharmacokinetics and Pharmacodynamics (PK-PD) of Venetoclax (VEN) in Patients With Acute Myeloid Leukemia (AML)","EUREKA-VEN","Inclusion Criteria:\n\n* Male or female patient aged of at least 18 years on day of signing informed consent\n* Patient with histologically-confirmed diagnosis of Acute Myeloblactic Leukaemia according to classification ELN 2022 (European Leukemia Net 2022)\n* Patient who has to initiate treatment venetoclax-azacitidine as first line. Note : triple associations with targeted therapy are not authorized\n* Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed.\n* Patient must be affiliated or benificiary of a social security system.\n\nExclusion Criteria:\n\n* Patient with acute promyelocytic leukemia (APL, AML3)\n* Patient with AML eligible to intensive chemotherapy\n* Patient previously treaed with venetoclax and\u002For azacitidine\n* Patient participating to another clinical trial with a medicinal product\n* Any condition that contraindicates blood sampling procedures required by the protocol\n* Any psychological, family, geographical, or social situation that, according to investigator's judgment, could potentially prevent the signing of an informed consent form and\u002For woulld likely interfere compliance with study procedures.\n* Patient under curatorship, guardianship or judicial protection\n* Pregnant or breast-feeding female patient.",{"count":177,"type":22},100,[86],"This is a prospective, multicenter, clinical-biological cohort study. Its objective is to assess the pharmacokinetics-pharmacodynamics (PK-PD) of venetoclax (VEN) in patients with Acute Myeloid Leukemia (AML).\n\nThis study involves only minimal risks and constraints related to the collection of biological samples (blood samples for PK testing) and the collection of clinical data. Therapeutic management of patients participating in this study is not changed. A total of 100 patients will be included in the study over a 12-month period. A maximum of 21 additional samples are planned, with a maximum of 12 mL of blood per sampling day (4 mL at each sampling time) for PK dosing of venetoclax.",[181],"Acute Myeloid Leukemia",[183,184,185,186,187],"Pharmacokinetics","Venetoclax","Pharmacodynamics","Cytologic response","Azole antifungal","2026-05-07",{"date":190,"type":38},"2026-05-08",{"date":192,"type":38},"2026-01-21",{"date":194,"type":22},"2029-01-01",{"name":44,"class":45},5,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":55,"minAge":19,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":206,"briefSummary":207,"conditions":208,"keywords":211,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":222,"leadSponsor":224,"locationsCount":135},"100637326","heterogeneity-of-oral-carcinogenesis-from-preneoplasia-to-invasive-squamous-cell-carcinoma-100637326","NCT07579507","Heterogeneity of Oral Carcinogenesis: From PrEneoplasia to Invasive Squamous Cell Carcinoma","HOPES","Inclusion Criteria:\n\n* I1: Male or female at least 18 years old.\n* I2: For Cohort A: patients with OSCC who undergo surgery. For cohorts B and C: patients with OPMD.\n* I3: Patient who has agreed to participate in this research and sign consent.\n* I4: Patient affiliated to a medical insurance.\n* I5: Patient who have not previously received any anticancer treatment (radiotherapy, chemotherapy, or immunotherapy)\n\nExclusion Criteria:\n\n* NI1: For cohorts B and C: Patient at high risk of bleeding, such as those receiving anticoagulant or antiplatelet therapy, those with coagulation disorders, or those with a history of severe bleeding within the two weeks prior to enrollment.\n* NI2: Pregnant or nursing woman.\n* NI3: Contraindication to general anesthesia.\n* NI4: Suspicion of rare tumor of particular histology other than squamous cell carcinoma (Sarcoma...).\n* NI5: Patient under curatorial or guardianship or placed under the protection of justice.",{"count":205,"type":22},150,[86],"The goal of this project is to characterise the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) present in the tumor and their normal (and OPMD) counterparts by scRNAseq in OSCC patients. Additionally, the study will evaluate the effectiveness of non-invasive cytobrushes as a diagnostic tool compared to traditional biopsies.",[209,210],"Oral Squamous Cell Carcinomas","Oral Potentially Malignant Disorder",[212,213,214,215,216,217],"scRNAseq","Heterogeneity of all cell population","OPMD","OSCC","cytobrush","RNAseq bulk","2026-05-05",{"date":220,"type":38},"2026-05-12",{"date":133,"type":22},{"date":223,"type":22},"2035-03",{"name":44,"class":45},{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":55,"minAge":232,"maxAge":233,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":236,"briefSummary":237,"conditions":238,"keywords":242,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":135},"100579674","lifestyle-intervention-among-participants-of-the-french-colorectal-cancer-screening-program-life-screen-100579674","NCT06827366","Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program (LIFE-SCREEN)","LIFE-SCREEN","Inclusion Criteria:\n\n* Having read the information note and agreeing to participate\n* Will and availability to be committed for a full year\n* At high risk for CRC but CRC negative\n* Affiliated to a health security system\n* Having a score on the adherence to the recommendation lower than or equal to 7 out of 9 at baseline.\n* Able to read, write and understand French\n\nExclusion Criteria:\n\n* Under a strict diet such as meal replacements, diets for co-morbidities such as diabetes\n* Immobile due to physical constraints (e.g. handicap that is not compatible with physical activities)\n* Extensive intestinal surgery such as colectomy or surgical resection of the colon\n* Chronic gastrointestinal illness (IBD, IBS, celiac disease)\n* Colorectal cancer confirmed or history of a primary cancer\n* Severe malnutrition\n* Pregnant\n* Participation in another lifestyle study\n\nNB : For this study, there is no exclusion period from other research, and participants can simultaneously take part in another study unless it concerns lifestyle.","35 Years","74 Years",{"count":235,"type":22},800,[86],"The investigators propose a randomized controlled trial to develop and evaluate the impact of promoting advice on diet and lifestyle recommendations for cancer prevention at colorectal cancer screening among individuals who may be at higher risk for colorectal cancer (CRC). The specific objectives of this study are to 1) develop a lifestyle intervention based on evidenced-based diet and lifestyle recommendations (i.e. those proposed by the World Cancer Research Fund (WCRF) and the French National Cancer Institute); 2) evaluate the effect of the intervention on the adherence to the target diet and lifestyle recommendations as well as other subjective health measures, including quality of life; 3) evaluate the effect of the intervention on anthropometrics.",[239,240,241],"Colorectal Cancer Screening","Colorectal Cancer Prevention","Colorectal Cancer",[243,244,245,246,247,248],"colorectal cancer","primary prevention","screening","physical activity","nutrition","recommendations","2026-04-29",{"date":218,"type":38},{"date":252,"type":38},"2026-01-26",{"date":254,"type":22},"2028-02-15",{"name":44,"class":45},{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":55,"minAge":19,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":135},"100631380","clinical-and-biogical-analyses-of-rectal-tumors-100631380","NCT07499921","Clinical and BIOgical Analyses of RECtal Tumors","BIOREC","Inclusion Criteria:\n\n* Male or female aged 18 or over\n* Patients who have undergone surgery for rectal cancer since January 1st, 2019\n* Histological diagnosis of rectal adenocarcinoma confirmed on a surgical sample\n\nExclusion Criteria:\n\n* Not applicable",{"count":264,"type":22},300,[86],"Rectal cancer is a common cancer with an incidence of approximately 14,000 new cases per year in France. The survival rate is approximately 50% at 5 years, ranging from 90% for patients with localized rectal cancer to 18% for patients with metastases.\n\nSurgery with local or complete exicion is the standard treatment for early stages. The implementation of Total Neoadjuvant Therapy (TNT) for locally advanced stages has led to a significant improvement in the prognosis for rectal cancer. The complete pathological response rate of aproximately 20% after TNT has led to the \"Watch and Wait\" strategy, which aims to avoid surgery and preserve the rectum, but there is currently no reliable method for identifying responders. Rectal tumors with mismatch repair defiency (MMRd) and\u002For High microsatellite instability (MSI-H) are considered resistant to neoadjuvant chemotherapy, but those patients can benefit from immunotherapy treatment. Identifying patients who will respond to immunotherapy is crucial for this type of treatment. Pre-existing immune infiltration within the tumor microenvironnement prior to any treatment is an important prognostic factor and could help predict response to immunotherapy, as well as neoadjuvant treatment. Studying the immune microenvironnement and how it changes during different treatments could therefore help identify responders for whom treatment without surgery could be considered in order to avoid the deterioration in quality of life often associated with this procedure in this type of cancer. Finally, analysis of residual tumor cells after chemotherapy and\u002For chemoradiotherapy could help identify possible mechanisms of resistance to current treatments and develop strategies to counter them.",[268],"Rectal Cancer","2026-04-27",{"date":271,"type":38},"2026-04-30",{"date":273,"type":22},"2026-05-01",{"date":275,"type":22},"2033-05-01",{"name":44,"class":45},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":286,"phases":4,"briefSummary":287,"conditions":288,"keywords":291,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":135},"100405686","prospective-study-of-immune-alterations-in-operable-breast-and-ovarian-carcinoma-100405686","NCT04562623","Prospective Study of Immune Alterations in Operable Breast and Ovarian Carcinoma","GYNECO-IMM&CO","Inclusion Criteria:\n\n* I1. Female patients aged ≥ 18 tears at time of inform consent signature.\n* I2. Patient with planned primitive tumor surgery listed below : High grade serous ovarian carcinoma (cohort A), Breast carcinoma SBR grade II or III \\> 3 cm (cohort B), Extended breast carcinoma In situ associated with invasive nodule carcinoma macroscopically visible and eligible to mastectomy (cohort C).\n\nNote : Patients previously treated by neoadjuvant chemotherapy are eligible and all chemotherapies are authorized.\n\n* I3. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures and should be willing to comply procedures required per protocol.\n* I4. Patient must be covered by a medical insurance.\n\nExclusion Criteria:\n\n* E1. Patient under guardianship or trusteeship.\n* E2. Cancer with constitutional BRCA1\u002F2 mutation.\n* E3. Previously treated by immunomodulators (PD1\u002FPDL1, CTLA4).\n* E4. Systemic treatment by an immunosuppressor (including, but not limited to, corticosteroids, azathioprine, methotrexate, thalidomide and anti-TNF-alpha) or by an immunostimulant within 2 weeks before inclusion, except corticosteroids listed below: inhaled corticosteroids, intranasal corticosteroids, topic corticosteroids, and systemic corticosteroids with prednisone or equivalent physiological dose ≤ 10 mg\u002Fday.\n* E5. Patient with known history of autoimmune disease including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis,systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipids syndrome, Wegener syndrome , Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vascularitis, or glomerulonephritis, B or C hepatitis infection, HIV infection.\n* E6. Patient with other active tumor except if the tumor is considered not to interfere with outcome measures following sponsor approval such as basal or squamous cell skin cancer. Patient previously treated for an other cancer and without relapse for at least one year are eligible.\n* E7. Pregnant or breastfeeding woman.",{"count":285,"type":22},160,"OBSERVATIONAL","GYNECO-IMM\\&Co is a prospective clinical and biological cohort ; this study aims to identify immune surveillance and escape mechanisms and also predictive biomarkers for survival patients who suffer from ovarian and breast carcinoma.",[289,290],"Ovarian Carcinoma","Breast Carcinoma",[292,293,294,295],"Ovarian cancer","Breast cancer","Immune alterations","Predictive biomarkers","2026-04-24",{"date":269,"type":38},{"date":299,"type":38},"2021-07-01",{"date":301,"type":22},"2031-07",{"name":44,"class":45},{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":55,"minAge":19,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":135},"100545729","phase-2-study-evaluating-the-efficacy-of-the-mydiet-software-tool-in-the-nutritional-management-of-patients-with-localized-and-resectable-gastric-or-esogastric-junction-cancer-100545729","NCT06385691","Study Evaluating the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.","Evaluation of the Efficacy of the myDIET Software Tool in the Nutritional Management of Patients With Localized and Resectable Gastric or Esogastric Junction Cancer.","MyDIET","Inclusion Criteria:\n\n* Patient 18 years of age or older at date of signing informed consent to participate;\n* Histologically proven diagnosis of gastric adenocarcinoma or OGJ;\n* Localized, resectable disease;\n* Patients with an indication for perioperative chemotherapy and\u002For immunotherapy validated in multidisciplinary consultation meeting, with a scheduled surgery date at least 1 month after enrolment;\n* Performance status (ECOG): 0-2;\n* Membership of a social security scheme;\n* Signed informed consent to participate.\n\nExclusion Criteria:\n\n* Other associated solid cancer or haemopathy;\n* Presence of severe comorbidity (Charlson index \\> 9)\n* Presence of unbalanced dysthyroidism;\n* History of gastric, duodenal or esophageal surgery;\n* Inability to comply with study requirements, including :\n\n  * Impossibility for the patient or his\u002Fher caregiver to connect to myDIET;\n  * Difficulty in understanding the written French language;\n  * Psychological incapacity (e.g. excessive vulnerability, psychiatric disorder) or physical incapacity (e.g. physical\u002Fmotor disability);\n* Patient under guardianship, curatorship or safeguard of justice;\n* Patients already participating in a clinical trial or interventional study likely to interfere with the evaluation of the primary endpoint.\n* Pregnant or breast-feeding patient.",{"count":312,"type":22},60,[26],"This is a prospective, single-center, single-arm Phase II study evaluating the efficacy of the myDIET software tool in the nutritional management of patients with localized and resectable esogastric junction cancer.",[62,316],"Oesogastric Junction Cancer",[318,319,246,320,125,321],"denutrition","software tool","postoperative treatment","immunotherapy","2026-04-23",{"date":324,"type":38},"2026-04-28",{"date":326,"type":38},"2024-04-26",{"date":328,"type":22},"2028-10-31",{"name":44,"class":45},{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":55,"minAge":19,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":286,"phases":4,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":135},"100363420","patakess-protocol--clinical-and-biological-analysis-of-exocrine-pancreatic-tumors-100363420","NCT04011982","PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors","PATAKESS","Inclusion Criteria:\n\n* Male or female patient 18 age or older\n* Patient operated on for exocrine pancreatic adenocarcinoma at Centre Léon Bérard since 01\u002F01\u002F2010.\n* Histological diagnosis of exocrine pancreatic adenocarcinoma confirmed with surgery specimen.\n\nExclusion Criteria:\n\n* Not applicable",{"count":264,"type":22},"PATAKESS is a monocentric non interventional cohort study (prospective (alive patients) and retrospective (dead patients with biological material from surgery and\u002For biopsies already collected)).\n\nPATAKESS consists of clinical and biological analyses of exocrine pancreatic tumors. Data are derived from tumor samples taken for routine health care purposes in patients managed at Centre Léon Bérard (Lyon-France) since January 2010. The main objective is to determine correlation between biological and clinical characterizations of patients suffering from exocrine pancreatic tumor.",[340],"Exocrine Pancreatic Cancer",[342,343,344,345],"Pancreatic cancer","Immune infiltrate","Molecular alterations","Tumor stroma",{"date":324,"type":38},{"date":348,"type":38},"2020-09-01",{"date":350,"type":22},"2028-04",{"name":44,"class":45},{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":55,"minAge":19,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":360,"briefSummary":361,"conditions":362,"keywords":367,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":4},"100635662","enumeration-and-functional-analysis-of-circulating-tumor-cells-for-homologous-recombination-a-prospective-single-center-study-on-advancedmetastatic-solid-tumors-100635662","NCT07555600","Enumeration and Functional Analysis of Circulating Tumor Cells for Homologous Recombination: a Prospective Single-center Study on Advanced\u002FMetastatic Solid Tumors","E-FACTOR","Inclusion Criteria:\n\n* Male or female patients ≥ 18 years at the day of signing informed consent.\n* Advanced\u002Fmetastatic breast, prostate, ovarian and pancreatic cancer patients potentially eligible to PARP inhibitor treatment as monotherapy or in combination as per respective SmPC (see Appendix 1) or IB if the PARPi treatment is investigational.\n* Patients who have understood, dated, and signed the written voluntary informed consent form before undergoing any procedure specific to the protocol.\n* Patients affiliated with or benefiting from medical insurance.\n\nExclusion Criteria:\n\n* Patients with secondary malignancy with the exception of basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer, prior malignancy and no evidence of recurrence for ≥ 2 years.\n* Patients presenting a psychological, familial, geographical, or social situation that, in the investigator's judgment, could potentially prevent the signing of informed consent and\u002For compliance with study procedures.\n* Pregnant or breast-feeding women.\n* Patients under judicial protection (guardianship, curatorship, or legal safeguard), adults under protection in accordance with Articles L.1121-6, L.1121-8, and L.1121-8-1 of the French Public Health Code, as well asindividuals not affiliated with a social security scheme or without equivalent health coverage.",{"count":264,"type":22},[86],"The goal of this clinical trial is to is to evaluate whether a correlation exists between functional HR status\u002FCTC enumeration in expanded CTCs measured before treatment initiation, and Progression Free Survival (PFS) under PARPi and\u002For DNA-damaging. This proof-of-concept study is a first step to confirm the hypothesis that a dual parameter approach combining (i) longitudinal monitoring of CTC enumeration and (ii) functional assessment of HR capacity in ex vivo expanded CTCs will enable accurate prediction of therapeutic response to PARPi and cytotoxic chemotherapies, particularly those involving cross-linking DNA-damaging agents such as platinum salts in 300 adult patients witch advances\u002Fmetastatic Ovarian, Breast, Prostate, or Pancreatic cancer potentially eligible to PARP inhibitor treatment as standards of care at the center Léon Bérard.\n\nThe main questions it aims to answer are:\n\n* Correlation between functional HR status\u002FCTC enumeration in expanded CTCs measured before treatment initiation and Progression Free Survival (PFS) under PARPi and\u002For DNA-damaging chemotherapy\n* Proportion of patients from whom ≥1 CTC colony can be successfully isolated and expanded ex vivo under predefined culture conditions\n* Distribution of CTC samples classified as HR-proficient vs HR-deficient based on assay-specific thresholds",[363,364,365,366],"Breast Cancer","Prostate Cancer","Pancreatic Cancer","Ovarian Cancer",[368,369,370],"CTC","PARPi","HR status","2026-04-21",{"date":249,"type":38},{"date":374,"type":22},"2026-05",{"date":376,"type":22},"2028-05",{"name":44,"class":45},{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":55,"minAge":19,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":23,"phases":388,"briefSummary":389,"conditions":390,"keywords":395,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":407},"100570373","phase-3-lymphocyte-sparing-and-radio-immunotherapy-in-head-and-neck-carcinoma-100570373","NCT06706401","Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma","A Multicenter, Randomised 2*2 Factorial Design Comparing Standard to Reduced-target Volume Radiotherapy With or Without All-trans Retinoic Acid (ATRA) in Patients With Lateralised Oropharyngeal, Laryngeal and Hypopharyngeal Squamous Cell Carcinoma.","LYSARI","Inclusion criteria :\n\nI1. Male or female patients aged ≥ 18 years old at time of inform consent signature.\n\nI2. Patients with primary head and neck tumour up to, but not crossing the midline, previously untreated with histologically-confirmed squamous cell carcinoma of:\n\n* the oropharynx p16-, larynx or hypopharynx : T1\u002FN2a-N2b, T2\u002FN0-N2b, T3\u002FN0-N2b (UICC 8th Ed.), or\n* the oropharynx p16+ : T1\u002FN1 (multiple nodes), T2-T3\u002FN0-N1 (UICC 8th Ed.).\n\nI3. Patients with lymph node staging assessed by an FDG-PET\u002FCT with no contralateral nodal uptake.\n\nI4. Patients amenable to treatment with RT or concomitant chemo-radiotherapy as decided by the treating physician as a function of tumor stage, tumor location, performance of the patients.\n\nI5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n\nI6. Adequate hematologic and end-organ function, defined by the following laboratory test results obtained within 7 days prior to randomisation :\n\nHematological (without transfusion within 2 weeks) :\n\n* Neutrophils count \\> 1.5 × 109 \u002FL\n* Platelets count \\> 75 × 109 \u002FL\n* WBC≥ 3.0 × 109 \u002FL\n\nHepatic function :\n\n* Total Bilirubin \\\u003C 1.5 × ULN (except for Gilbert's syndrome which will allow bilirubin ≤ 3 ULN).\n* Alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n* Aspartate aminotransferase (AST) ≤ 2.5 × ULN.\n* Albumin \\>3.0g\u002FdL\n\nRenal function :\n\n* Serum creatinine \\\u003C 1.5 ×ULN.\n\nI7. QTcF ≤450ms for men and 470ms for women, from 3 electrocardiograms on screening ECG, within 7 days prior randomisation.\n\nI8. Women patients of child-bearing potential are eligible, provided they have a negative serum or urine pregnancy test within 7 days prior randomisation, and agrees to use adequate contraception for up to 1 month after the end of study treatments.\n\nI9. Fertile men must agree to use an effective method of contraception during the study and for up to 1 month after the end of study treatments.\n\nI10. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and should be able and willing to comply with study visits and procedures as per protocol.\n\nI11. Patients must be covered by a medical insurance in country where applicable.\n\nExclusion criteria :\n\nE1. Patient with primary tumor crossing the midline or patients with bilateral primary tumors.\n\nE2. Patients with T1-N0 (p16-), T1-N1 (p16-), T1-N0 (p16+), T4 (p16- and p16+), bilateral lymph nodes or nodal disease more than 6 cm (p16- and p16+).\n\nE3. Patients with unknown primary tumor size as per TNM i.e. T0-N1 to T0-N3, p16- or p16+.\n\nE4. Patients with contralateral FDG-PET\u002FCT nodal uptake.\n\nE5. Patient with any previous anti-cancer therapy for HNSCC (all prior treatment are forbidden: chemotherapy, radiotherapy, targeted therapy, immunotherapy or any other therapy approved or experimental).\n\nE6. Patient with malignancies other than HNSCC within 3 years prior to randomisation with the exception of adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localised prostate cancer treated surgically with curative intent.\n\nE7. Patient with ongoing or anticipation of need for systemic immunosuppressive medication (including, but not limited to, glucocorticoids, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents); with the exceptions of intranasal, inhaled or topical corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid.\n\nE8. Patient with ongoing or anticipation of need for systemic immunostimulatory agents (including, but not limited to, interferons and IL-2).\n\nE9. Patient with concurrent treatment with any other anti-cancer treatment, approved or investigational agent or participation in another clinical trial with therapeutic intent.\n\nE10. Patient with infectious diseases :\n\n* Severe infection within 4 weeks prior to randomisation, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia,\n* Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening),\n* Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA at screening,\n* HIV infection,\n* Active tuberculosis.\n\nE11.Patient with any psychological, cognitive, familial, sociological or geographical condition potentially hampering compliance with the study protocol, completion of patient reported measures and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n\nE12. Patient with known hypersensitivity to tretinoin, other retinoids, soya, peanut or to any of the excipients of vesanoid.\n\nE13. Patient with known malabsorption syndrome and\u002For unable to swallow oral medication.\n\nE14.Patient with ongoing or expected need for concomitant treatment with vitamin A, tetracyclines, other retinoids, anti-fibrinolytic agent, and strong inducers or inhibitors of CYP3A4.\n\nE15.Pregnant or lactating woman.",{"count":387,"type":22},460,[59],"The aim of this study is to investigate the effect of ATRA (Vesanoid) and the effect of tailored radiotherapy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx.",[391,392,393,394],"Oropharynx Cancer","Larynx Cancer","Hypopharynx Cancer","Primary Head and Neck Tumor",[396,397,398,399,400],"Localised squamous cell carcinoma of head and neck","Previously untreated","Standard radiotherapy","Tailored radiotherapy","Vesanoid",{"date":296,"type":38},{"date":403,"type":38},"2025-02-20",{"date":405,"type":22},"2029-01",{"name":44,"class":45},8,{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":55,"minAge":19,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":433},"100569308","phase-3-study-of-a-strategy-integrating-adjuvant-radiation-therapy-versus-strategy-based-on-monitoring-in-the-treatment-of-carcinomas-spinocellular-with-high-risk-of-recurrence-100569308","NCT06692556","Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence","Randomized Comparative Multicenter Phase III Study of a Strategy Integrating Adjuvant Radiation Therapy Versus Strategy Based on Monitoring in the Treatment of Carcinomas Spinocellular With High Risk of Recurrence","SPINO-RT","Inclusion Criteria:\n\nI1. Patients aged ≥ 18 years at the time of signing the informed consent form; I2. Patients with histologically confirmed localized cutaneous squamous cell carcinoma;\n\nNote: Patients with carcinoma of the external auditory canal may be included in the study;\n\nI3. Patients treated with complete surgical excision (R0), regardless of the margin (submillimeter or supramillimeter);\n\nI4. Disease with a high risk of recurrence defined by one of the following scenarios:\n\n* presence of microscopic EPN without any other risk factors;\n* presence of microscopic EPN with a single other risk factor;\n* presence of 2 risk factors other than microscopic EPN;\n* presence of 3 risk factors other than microscopic EPN;\n\nNote: The risk factors considered are immunosuppression (limited to untreated hematologic disease), a tumor diameter \\>20 mm (longest axis, measured preferably clinically, or, failing that, histologically), a specific location (lip\u002Fear\u002Ftemple), deep invasion (tumor thickness \\>6 mm (Breslow) or invasion beyond the subcutaneous fat), poor differentiation, or desmoplasia;\n\nI5. Patient informed and having signed a consent form to participate in the study; I6. Patient enrolled in a health insurance plan (or beneficiary of such a plan).\n\nExclusion Criteria:\n\nNI1. Patients with in situ or mixed CEC; NI2. History of CEC with a high risk of recurrence in the same lymphatic drainage area (head and neck, trunk, or limb) within 2 years prior to the randomization date; NI3. History of CEC treated with systemic therapy; NI4. Patients with SCC localized to the endonasal, intraoral, anogenital, or vulvar mucosa;\n\nNI5. Patients with recurrent SCC or SCC at very high risk of recurrence defined by one of the following criteria:\n\n* EPN with ≥ 2 other risk factors,\n* \\> 3 risk factors,\n* bone invasion,\n* immunosuppression due to immunosuppressive treatments (regardless of the reason). NI6. Patients with CEC presenting a single risk factor other than EPN; NI7. Patient with CEC and lymph node or distant metastasis; NI8. Patient with a history of cancer undergoing systemic and\u002For locoregional anticancer treatment;\n\nNote: Local treatment of cutaneous keratoses with fluoropyrimidines is permitted outside the theoretical radiation field);\n\nNI9. Patient with a contraindication to radiation therapy; NI10. Patient with a history of radiation therapy to the site of the lesion; NI11. Participation in another clinical trial that may interfere with the assessment of the primary endpoint; NI12. Patient under legal guardianship or conservatorship, or deprived of liberty; NI13. Pregnant or breastfeeding woman.",{"count":417,"type":22},266,[59],"The goal of this clinical trial is to evaluate a strategy integrating adjuvant radiation therapy versus strategy based on monitoring in the treatment of carcinomas spinocellular with high risk of recurrence (SCC).\n\nThe investigators will compare the disease-free survival (DFS) of patients treated with adjuvant radiation therapy versus surveillance in high risk of recurrence SCC.\n\nThe main question it aims to answer is:\n\nIs DFS different between the \"adjuvant radiotherapy\" group and the \"surveillance\" group?\n\nParticipants will:\n\n* be distributed in one of the two arms\n* will be followed up every 4 months for 2 years, then every 6 months (clinical examination, identification of concomitant treatments, imaging, quality-of-life questionnaire)\n* followed up until their death or their progression whether local, regional or metastatic",[421],"Cutaneous Squamous Cell Carcinoma (CSCC)",[423,424,425,426],"Squamous cell carcinomas at high risk of recurrence","Adjuvant radiotherapy","Surveillance","Peri Nervous System Sheathing",{"date":296,"type":38},{"date":429,"type":38},"2025-02-21",{"date":431,"type":22},"2031-06",{"name":44,"class":45},28,{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":55,"minAge":19,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":23,"phases":443,"briefSummary":444,"conditions":445,"keywords":449,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":473},"100450974","phase-2-a-prospective-randomized-multicenter-comparative-study-of-the-efficacy-of-imatinib-resumption-combined-with-atezolizumab-versus-imatinib-resumption-alone-in-patients-with-unresectable-advanced-gastrointestinal-stromal-tumors-gist-after-failure-of-standard-treatments-100450974","NCT05152472","A Prospective, Randomized, Multicenter, Comparative Study of the Efficacy of Imatinib Resumption Combined With Atezolizumab Versus Imatinib Resumption Alone in Patients With Unresectable Advanced Gastrointestinal Stromal Tumors (GIST) After Failure of Standard Treatments","ATEZOGIST","INCLUSION CRITERIA :\n\nI1. Male or female ≥ 18 years at the day of consenting to the study;\n\nI2. Patients must have histologically confirmed diagnosis of GIST (within the French Reference Network in Pathology of Sarcomas - RRePS network);\n\nI3. Locally advanced or metastatic disease confirmed as measurable according to the RECIST V1.1 (Appendix 1);\n\nI4. Patients who previously failed to at least imatinib, sunitinib and then regorafenib. Failure is defined for Imatinib as progressive disease, and for sunitinib and regorafenib as progressive disease and\u002For intolerance;\n\nI5. Performance Status of the ECOG of 0 or 1;\n\nI6. Adequate bone marrow and organ function defined by the following laboratory results:\n\na. Bone marrow: i. Hemoglobin ≥ 9.0 g\u002Fdl, ii. Absolute Neutrophils Count (ANC) ≥ 1.5 G\u002Fl, iii. Lymphocytes count ≥ 0.5 G\u002Fl, iv. Platelets ≥ 100 G\u002Fl;\n\nb. Coagulation: i. Prothrombin time ≤ 1.5 x Upper Limit of the Normal (ULN) for patients without therapeutic anticoagulation.\n\nPatients with therapeutic anticoagulation must have stable dose of treatment.\n\nc. Hepatic function: i. Total serum bilirubin ≤ 1.5 x ULN (except patients with Gilbert's syndrome who must have total serum bilirubin ≤ 3.0 x ULN), ii. Transaminases (ASAT\u002FALAT) ≤ 2.5 x ULN (or ≤ 5.0 x ULN in case of documented liver metastases) iii. Alkaline Phosphatases ≤ 2.5 x ULN (or ≤ 5.0 x ULN in case of documented bone metastases),\n\nd. Renal function: i. Serum creatinine ≤ 1.5 x ULN or Cr. Cl. ≥ 40ml\u002Fmin\u002F1.73m² (MDRD or CKD-EPI formula);\n\nI7. Willingness and ability to comply with the study requirements;\n\nI8. Signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrolment;\n\nI9. Women of childbearing potential are required to have a negative serum pregnancy test within 72 hours prior to study treatment start. A positive urine test must be confirmed by a serum pregnancy test;\n\nI10. Women of childbearing potential and male patients must agree to use adequate highly effective contraception for the duration of study participation (Appendix 3);\n\nI11. Patient must be covered by a medical insurance;\n\nEXCLUSION CRITERIA :\n\nE1. Prior malignancy within the last 3 years except for locally curable disease with no sign of relapse;\n\nE2. Patients in whom imatinib had been already reintroduced after sunitinib as second line;\n\nE3. Known D842V mutation in Exon 18 of PDGFRA;\n\nE4. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4 , anti-TIGIT, anti PD-1,and anti PD-L1 therapeutic antibodies;\n\nE5. Any approved anticancer therapy (chemotherapy, hormonal therapy or radiotherapy) or treatment with any investigational product within 2 weeks or within 5 elimination half-lives (whichever is longer) prior to study treatments start;\n\nE6. Residual adverse events from prior anticancer therapy that has not resolved to grade ≤1, except for alopecia and lab values (provided that inclusion criteria described in section 6.1 are met);\n\nE7. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.\n\nAsymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:\n\n* Measurable disease, per RECIST v1.1, must be present outside the CNS.\n* The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.\n* The patient has not undergone stereotactic radiotherapy within 7 days prior to randomization, whole-brain radiotherapy within 14 days prior to randomization, or neurosurgical resection within 28 days prior to randomization.\n* The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted.\n* Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).\n* There is no evidence of interim progression between completion of CNS-directed therapy and randomization.\n* Spinal cord compression not definitively treated with surgery and\u002For radiation, and\u002For previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for 2 weeks prior to screening.\n* History of leptomeningeal disease.\n\nE8. Patients using or require to use while on the study of any prohibited concomitant and\u002For concurrent medications (see section \"Prohibited concomitant\u002Fconcurrent treatments) :\n\n* Live, attenuated vaccines within 28 days prior to enrolment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (e.g. Flu-Mist®) are live attenuated vaccines, and are not allowed during the study active period.\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents) within 2 weeks prior to C1D1, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n* Patients who receive acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Medical Monitor confirmation.\n* Patients who receive mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroid.\n* Systemic immunostimulatory agents (including, but not limited to, interferons and IL-2) are prohibited within 4 weeks or five half-lives of the drug (whichever is longer) prior to C1D1.\n* Traditional herbal medicines since the ingredients of many herbal medicines are not fully studied and their use may result in unanticipated drug-drug interactions that may cause or confound assessment of toxicity,\n\nE9. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix 4 for a more comprehensive list of pre-existing autoimmune diseases and immune deficiencies), with the following exceptions:\n\n* Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n* Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n* Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n* Rash must cover less than 10% of body surface area\n* Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n* No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n\nE10. History of severe allergic \u002F anaphylactic reaction or other hypersensitivity reactions to:\n\n* chimeric or humanized antibodies or fusion proteins,\n* biopharmaceuticals produced in Chinese hamster ovary cells, any active substance or to any of the chemical excipients of atezolizumab (refer to its IB) or imatinib (refer to its respective SmPC)\n\nE11. Patients with active infectious disease:\n\n* severe infections within 4 weeks prior to randomisation including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia,\n* active infection requiring or have required treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection) are eligible for the study.\n* active B or C hepatitis infection, Note: Patients with past Hepatitis B Virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen \\[anti-HBc\\] antibody test) are eligible. Patients positive for Hepatitis C Virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n* active tuberculosis\n* HIV infection\n\nE12. Active or prior history of primary immunodeficiency;\n\nE13. Major surgical procedure within 28 days prior to study treatments start, or need for a major surgery during the course of the study;\n\nE14. Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within :\n\n* 6 months after the final dose of study treatment for patients included in the standard arm (imatinib alone)\n* 11 months after the final dose of study treatment for patients included in the experimental arm (imatinib + atezolizumab) Women of childbearing potential must have a negative pregnancy test result within 72 hours prior to treatment start (any urine positive pregnancy test must be confirmed by a serum pregnancy test prior to treatment start);\n\nE15. Patient that impairs their ability to swallow and retain imatinib or with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of imatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\n\nE16. Clinically significant unrelated systemic illness (e.g., significant cardiac, pulmonary, hepatic, or other organ dysfunction) that would compromise the patient's ability to tolerate study treatment or would likely interfere with study procedures or results.\n\nE17. Patients under tutorship or curatorship.",{"count":442,"type":22},110,[26],"This trial is a prospective, randomized (1:1 ratio), multicenter, comparative and phase II study, conducted in patients with unresectable advanced gastrointestinal stromal tumors (GIST) after failure of imatinib (disease progression),sunitinib and regorafenib (either disease progression or intolerance)\n\nIn the first arm, patients will be treated with imatinib + atezolizumab (experimental arm), whereas in the second arm, patients will be treated with imatinib alone (control arm).\n\nThe comparison between this two arms will allow to compare whether or not atezolizumab and imatinib is efficient for disease control, in terms of Progression-Free Survival improvement.",[446,447,448],"Unresectable Gastrointestinal Stromal Tumor (GIST)","Locally Advanced Gastrointestinal Stromal Tumor (GIST)","Metastatic Gastrointestinal Stromal Tumor",[450,451,452,453,454,455,456,448,457,458,459,460,461,462,463,464,465,466],"Oncology","Imatinib","Atezolizumab","Immunotherapy","Phase II","Unresectable Gastrointestinal Stromal Tumor","Locally Advanced Gastrointestinal Stromal Tumor","GIST","Tyrosine kinase inhibitor","Progression-Free Survival","Best Response Rate","Objective Response Rate","Time to Treatment Failure","Overall Survival","Quality of Life","Tolerability","Randomization",{"date":296,"type":38},{"date":469,"type":38},"2022-01-14",{"date":471,"type":22},"2027-10",{"name":44,"class":45},13,{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":55,"minAge":19,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":488,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":504,"locationsCount":505},"100371451","phase-2-a-study-evaluating-the-activity-of-anti-cancer-treatments-targeting-tumor-molecular-alterationscharacteristics-in-advanced--metastatic-tumors-100371451","NCT04116541","A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations\u002FCharacteristics in Advanced \u002F Metastatic Tumors.","MegaMOST - A Multicenter, Open-label, Biology Driven, Phase II Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations \u002FCharacteristics in Advanced \u002F Metastatic Tumors.","MegaMOST","Inclusion Criteria:\n\n* Male or female patients aged of at least 18 years on day of signing informed consent.\n* Patients with histologically confirmed diagnosis of metastatic disease or unresectable locally advanced malignancy that is resistant or refractory to standard therapies or for which standard therapies does not exist or is\u002Fare not considered appropriate by the investigator.\n* A multidisciplinary molecular board must have recommended the specific MTT based on the following documented actionable alterations:\n\n  * Cohort HDM201-Ribociclib : amplification of CDK6 and\u002For CDK4, and\u002For CDKN2A homozygous deletion, and\u002For amplification of CCND1 and\u002For CCND3 with no deletion\u002Flosses more than single copy of RB1 by copy number and P53 wild-type.\n  * Cohort Cabozantinib : AXL, MET, VEGFR, VEGF, RET, ROS1, MER, TRKB, TIE-2 and\u002For Tyro3 activating mutations and\u002For amplification, and\u002For NTRK translocation and\u002For ROS1 translocation, and\u002For MET translocation.\n  * Cohort Alectinib : Activating ALK alterations: translocation, or selected mutations, or activating rearrangements following validation by central molecular tumor board of Centre Léon Bérard.\n  * Cohort Regoranib : Activating mutation and\u002For amplification and\u002For rearrangement of VEGFR1-3, TIE-2, KIT, RET, RAF1, BRAF (other than V600 mutations), CRAF, HRAS, PDGFR, FGFR1-2, FLT3 and\u002For CSFR1, and\u002For amplification of the ligands, and\u002For biallelic inactivation of SMAD4, following validation by central molecular tumor board of Centre Léon Bérard.\n  * Cohort Trametinib : Activating mutation and\u002For amplification of KRAS (except all KRAS G12 mutations), NRAS, HRAS and\u002For MAP2K; and\u002For biallelic inactivation of NF1; and\u002For activating mutation PTPN11; and\u002For amplification or translocation of BRAF, and\u002For translocation RAF1\n  * Cohort Trametinib + Dabrafenib : BRAF V600 mutation.\n  * Cohort Avapritinib : Activating mutations of KIT exon 17 or PDGFRA exon 18 associated or not to mutation on KIT exon 11 or PDGFRA exon 12\u002F14\n* Previously treated by at least one prior line of treatment in the advanced\u002Fmetastatic setting except for specific tumor type with no standard treatment approved and reimbursed in France following sponsor approval.\n* Documented radiological disease progression as per RECIST v1.1 and presence of at least one measurable lesion according to RECIST 1.1 criteria based on screening tumor assessment.\n* Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.\n* Adequate organ function\n* Adequate cardiovascular function\n* Specific toxicities related to any prior anti-cancer therapy must have resolved to grade ≤1 , except for alopecia (all grades), grade 2 neuropathy or anemia.\n* Unless infertility is proven, men must agree to use effective contraception\n* Women of child-bearing potential must have a negative serum pregnancy test within 7 days of first dose of study drug and agree to use effective contraception\n* Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study procedures as per protocol.\n* Patient must be covered by a medical insurance.\n\nExclusion Criteria:\n\n* Patients amenable to therapy with curative intent.\n* Patients participating to another clinical trial with a medicinal product.\n* Patients previously treated with similar MTT meaning any agent targeting the same signaling pathways components.\n* Patients unable to swallow oral medication.\n* Patients with known hypersensitivity to excipients\n* Patients with symptomatic central nervous system (CNS) metastasis who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS disease.\n* Patients with secondary malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints and is approved by the sponsor. Examples of the latter include: basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized prostate cancer, prior malignancy and no evidence of recurrence for ≥ 2 years.\n* Patients using, or requirement to use while on the study, or not respecting the minimal wash-out period of medications\n* Any clinically significant and\u002For uncontrolled medical disease that could compromise the patient's ability to tolerate study drug or would likely interfere with study procedures or results.\n* Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Patients who are pregnant or breastfeeding women or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through after the last dose of trial treatment (depanding on cohort).",{"count":483,"type":22},455,[26],"This trial is a multicenter, open-label, biology driven, phase II study using a sequential Bayesian design, aiming to assess the efficacy and safety of different Matched Targeted Therapy (MTT) in independent and parallel cohorts of treatment.\n\nPatients will be assigned to a treatment cohort based on molecular alterations\u002Fcharacteristics detected on tumor sample from primary tumor or metastatic lesion.\n\nIn this protocol, several MTTs treatment cohorts are planned. This study is designed with the flexibility to open new MTTs treatment cohorts and to close existing MTTs treatment cohorts that demonstrate no clinical benefit. Each treatment cohort will be driven separately even though procedures, quality control and reporting, will be common. The protocol will be amended in order to include new treatments or combinations that emerge as being of interest for patients with advanced\u002Fmetastatic cancers.\n\nAll eligible patients will receive study drugs as long as patient experiences clinical benefit in the opinion of the investigator, or until unacceptable toxicity, or until symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status, or withdrawal of consent.\n\nPatients will be permitted to continue study treatment after progressive disease according to RECIST v1.1 if they meet all of the following criteria and following validation of the Sponsor:\n\n* Evidence of clinical benefit as assessed by the investigators,\n* Absence of symptoms and signs (including worsening of laboratory values; e.g., new or worsening hypercalcemia) that indicate unequivocal progression of disease,\n* No decline in ECOG Performance Status (PS) that can be attributed to disease progression.",[487],"Malignant Solid Tumor",[489,490,491,492,493,494,495,496,497,498,499],"Metastatic Solid Neoplasm","Advanced Solid Tumor","Genomic alteration","Targeted therapy","Cabozantinib","Ribociclib","HDM201","Alectinib","Trametinib","Dabrafenib","Avapritinib",{"date":296,"type":38},{"date":502,"type":38},"2020-01-28",{"date":471,"type":22},{"name":44,"class":45},10,{"id":507,"slug":508,"hasResults":12,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":12,"sex":55,"minAge":19,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":286,"phases":4,"briefSummary":515,"conditions":516,"keywords":517,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":46},"100350360","colon-im--microbiota-and-immune-infiltrate-in-normal-dysplastic-and-neoplastic-colorectal-tissue-100350360","NCT03841799","COLON-IM : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue","COLON-IM : Prospective Cohort Study About Colorectal Environment : Microbiota and Immune Infiltrate in Normal, Dysplastic and Neoplastic Colorectal Tissue","Inclusion Criteria:\n\n* I1. Male or female patient 18 age or older at time of inform consent signature.\n* I2. Patient Cohort A : with benign or malignant colorectal lesion (from stage I to III according to TNM\u002FUICC classification) eligible to surgery, not previously be treated with an anticancer systemic agent (any type) and not be previously exposed to radiotherapy.\n\nCohort B : with localised colon\u002Frectume adenocarcinoma, eligible to surgery, and treated by radiotherapy and\u002For pre-operative chemotherapy\n\n* I3. Patient should be able and willing to comply with procedures as per protocol.\n* I4. Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed.\n* I5. Patient must be covered by a medical insurance.\n\nExclusion Criteria:\n\n* E1. Pregnant or breast-feeding female patient.\n* E2. Prior treatment with : Any immunomodulatory treatment (streroids, immunosuppressive therapies) within 4 weeks prior inclusion, Any antibiotics within 8 weeks prior inclusion.\n* E3. Patients with secondary malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints and is approved by the sponsor. Examples of the latter include: in-situ carcinoma of the cervix treated adequately, basal or squamous cell carcinoma of the skin. Patients previously treated for another cancer type and without evidence of relapse for at least 1 year are eligible.\n* E4. Patient with inflammatory disease or autoimmune disease.\n* E5. Patient under curatorship, guardianship or judicial protection.",{"count":514,"type":22},400,"The primary objective of COLON-IM is to describe colorectal tissue microenvironment (neutrophils infiltrate) of patients with benign or malignant colorectal lesion (from stage I to III according to Tumor Node Metastasis (TNM)\u002F Union for International Cancer Control (UICC) classification).",[241],[518,519,343],"Microbiota","Microenvironment colorectal tissue",{"date":296,"type":38},{"date":522,"type":38},"2019-05-02",{"date":524,"type":22},"2029-12",{"name":44,"class":45},{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":55,"minAge":534,"maxAge":535,"enrollmentInfo":536,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":543,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":555,"locationsCount":135},"100505213","impact-of-a-multidisciplinary-end-of-treatment-day-hospital-on-the-quality-of-life-of-adolescents-and-young-adults-with-cancer-100505213","NCT05858424","Impact of a Multidisciplinary End-of-treatment Day Hospital on the Quality of Life of Adolescents and Young Adults With Cancer","Impact Evaluation of a Multidisciplinary End-of-treatment Day Hospital on the Quality of Life of Adolescents and Young Adults With Cancer","HOPAYA","Inclusion Criteria:\n\n1. Be aged between 15 and 25 years at diagnosis. This age range corresponds to the one chosen at the Leon Berard comprehensive cancer care center (CLB) for support in the AYA Department.\n2. Be previously treated at the Paediatric Hematology and Oncology Institute (IHOPe) and\u002For at CLB in AYA Department\n3. For a solid tumor or a lymphoma\n4. Be in complete oncological response at the end of treatment; have received their end-of-treatment evaluation\n5. Have finished their therapy since less than 2 months (therapy is defined by any treatment received, including maintenance)\n6. Be capable of understanding, reading and writing French\n7. Be affiliated to a health insurance plan\n8. Have been informed of the study and have consented to it\n9. For minor patients, consent of parents and\u002For legal tutors must be collected.\n\nExclusion Criteria:\n\n1. cannot be followed-up throughout the duration of the study (12 months),\n2. be deprived of liberty by a court or administrative decision,\n3. have not consent to participate or are incapable of objecting in an informed manner.","15 Years","25 Years",{"count":537,"type":22},214,[86],"Rational: 800 cases of cancer per year are diagnosed in France among Adolescents and Young Adults (AYA). This population has been specifically targeted since 2008 by the INCa, leading to the development of structures entirely dedicated to its management. Indeed, the occurrence of cancer in this period of transition leads to specific problems, which require a special attention. The various measures taken since then (Cancer Plan 2014-2019, DGOS instruction in 2016, 10-year strategy to fight cancer 2021-2030) have enabled the implementation of multidisciplinary structures, resulting in better access to care, and consideration of the social, family and relational dimensions of this population. However, the transition from the end of oncology treatment to the follow-up period remains a sensitive period, generating both positive (relief, joy) and negative feelings (uncertainty, feelings of abandonment, anxiety).\n\nThe investigators therefore hypothesize that the creation of a multidisciplinary end-of-treatment day hospital (DH) involving at least one medical interview, one psychological consultation and one social interview, would improve the quality of life of these former patients during the first year of oncology follow-up.\n\nMethod: This is a clinical research study conducted in a single centre. At their last visit for treatment, the study will be offered to patients. If the participants agree to participate, they will be randomized to benefit from DH in addition to their planned follow-up with their oncologist. The main objective is to compare the quality of life of former patients according to participation in DH or not. 210 patients will be included for a 20-month recruitment period.\n\nExpected results: Throughout the development of DH, the investigators plan to improve the quality of life of former patients during this transitional phase.",[541,542],"Solid Tumor","Lymphoma",[544,545,546,547,450,548],"Survivorship","Supportive care needs","Adolescents and Young Adults","Post-treatment","Quality of life","2026-04-17",{"date":551,"type":38},"2026-04-22",{"date":553,"type":38},"2022-11-29",{"date":40,"type":22},{"name":44,"class":45},{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":55,"minAge":534,"maxAge":535,"enrollmentInfo":563,"targetDuration":4,"studyType":23,"phases":564,"briefSummary":565,"conditions":566,"keywords":568,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":135},"100632560","evaluation-of-the-effects-of-equicoaching-on-social-reintegration-among-young-adults-who-have-been-treated-for-cancer-100632560","NCT07515274","Evaluation of the Effects of Equicoaching on Social Reintegration Among Young Adults Who Have Been Treated for Cancer","EQUICAP","Inclusion Criteria:\n\n* Have been treated for a malignant oncological or hematological condition.\n* Be between 15 and 25 years of age at the time of cancer diagnosis. This age range corresponds to that chosen by the Leon Berard Cancer Center (CLB) and the Institute of Pediatric Hematology and Oncology (IHOPe) for the Adolescents and Young Adults with Cancer (DAJAC) program\n* Have been treated at IHOPe\u002FCLB as part of the DAJAC program\n* Have completed intensive treatment within the last twelve months.\n* Be able to understand, read, and write French\n* Be affiliated with a health insurance plan\n* Have been informed about the study and have given consent\n\nFor minors:\n\n* All of the above criteria\n* Parent\u002Flegal guardian informed about the study and having given consent\n\nExclusion Criteria:\n\n* Patient deprived of liberty by judicial or administrative decision\n* Pregnant or breastfeeding women",{"count":505,"type":22},[86],"This is a category 2 human research study (RIPH), interventional, single-center, prospective, open-label.\n\nThe primary objective of this study is to qualitatively assess the effects of equicoaching on social reintegration in young adults who have been treated for cancer.\n\nThe secondary objectives are to evaluate the contribution of equicoaching to:\n\n1. Self-confidence;\n2. Well-being\n3. Quality of life Satisfaction with equicoaching will also be evaluated.",[567],"Cancer Pediatric",[569],"cancer pediatric","2026-04-07",{"date":572,"type":38},"2026-04-13",{"date":574,"type":22},"2026-04-05",{"date":576,"type":22},"2027-01-31",{"name":44,"class":45},{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":286,"phases":4,"briefSummary":588,"conditions":589,"keywords":590,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":135},"100632564","evolution-of-clinical-and-motivational-constructs-during-the-physical-activity-program-kheops-already-offered-to-patients-at-the-centre-lon-brard-100632564","NCT07515326","Evolution of Clinical and Motivational Constructs During the Physical Activity Program KHEOPS, Already Offered to Patients at the Centre Léon Bérard","Evolution of Psychological Determinants of Physical Activity and Cancer-related Psychological Symptoms in Patients Undergoing Treatment for Breast Cancer and Following a Physical Activity Program","CANDY","Inclusion Criteria\n\n* Woman aged ≥ 18 years\n* Diagnosed with non-metastatic breast cancer\n* Undergoing treatment or after surgery\n* Participating in the CLB KHEOPS program, either face-to-face or distance learning\n* Have a smartphone, computer or tablet to answer the 2 weekly online weekly online questionnaires and to follow APA sessions for patients following the patients following the KHEOPS program remotely\n* Having received a study information note and having made a declaration of non-opposition\n* Affiliated with a social security scheme\n* Able to read, write and understand French\n\nExclusion Criteria:\n\n* Unable to be followed for medical, social, family, geographical or psychological reasons, for the duration of the study.\n* Have difficulty completing a questionnaire alone\n* Deprived of liberty by judicial or administrative decision, or adults protected by law\n* Concurrently participating in another PA study",{"count":587,"type":22},80,"CANDY is a single-center, prospective study designed to observe the evolution of clinical and motivational constructs during the APA program KHEOPS program, already offered to patients at the Centre Léon Bérard (CLB).\n\nThe main aim of the CANDY study is to observe the evolution of psychological constructs derived from M-PAC during a 13-week KHEOPS APA program in women undergoing treatment for breast cancer.\n\nSecondary objectives are:\n\n* to examine the feasibility of psychological measures and participation in the KHEOPS program\n* to observe cancer-related psychological symptoms during the KHEOPS program and to investigate the links between the temporal evolution of psychological factors (clinical and motivational) and adherence to the KHEOPS program, as well as the level of post-program PA during and after the KHEOPS program in patients followed at the CLB.",[363],[293,591,592],"physical activty","KHEOPS program","2026-03-30",{"date":570,"type":38},{"date":596,"type":38},"2024-12-18",{"date":598,"type":22},"2026-09-30",{"name":44,"class":45},{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":608,"minAge":19,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":23,"phases":611,"briefSummary":612,"conditions":613,"keywords":615,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":167},"100484488","impact-of-a-physical-activity-program-to-reduce-long-term-cancer-related-fatigue-in-metastatic-testicular-germ-cell-tumor-patients-100484488","NCT05588700","Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients","A National, Multicenter, Phase III Randomized Controlled Trial to Assess the Impact of a One-year Supervised Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients","STARTER","Inclusion Criteria:\n\n* Men ≥18 years\n* With a metastatic germ cell tumor histologically confirmed (seminoma and non-seminoma)\n* Who have already undergone an orchidectomy (since the 16th december, this criteria was deleted).\n* Having a first line of chemotherapy planned with BEP, EP or VIP\n* Having a smartphone (i.e. to connect the activity tracker)\n* PS \\\u003C or = 2\n* Whose ability to practice an adapted physical activity (APA) has been certified by a medical certificate issued by the referring oncologist or the investigating physician\n* Available and willing to participate in the study for the duration of the intervention and follow-up,\n* Able to understand, read and write French,\n* Affiliated with a social security scheme,\n* Having dated and signed an informed consent.\n\nExclusion Criteria:\n\n* Presence of symptomatic bone and\u002For brain metastases\n* Central nervous system involvement with neurological deficits preventing walking\n* History or coexistence of another primary cancer (apart from in situ cancer of any location and\u002For basal cell skin cancer and\u002For basal cell skin cancer and\u002For a cancer in complete remission for more than 3 years),\n* Contraindication to physical activity (e.g. uncontrolled hypertension, uncontrolled heart disease) uncontrolled heart disease),\n* Unable to be followed for medical, social, family, geographical or psychological reasons, during the entire study period,\n* Deprived of liberty by judicial or administrative decision, or adults protected by law,\n* Concurrent participation in another study in PA.","MALE",{"count":610,"type":22},236,[86],"Testicular germ cell tumor (TGCT) is the most common malignancy in men between 15 and 40 years. Although TCGT survivors have a good survival prognosis, they suffer from short- and long-term sequelae such as chronic fatigue, psychological disorders, cardiovascular toxicities and second malignancies. The benefits of physical activity (PA) during treatments have been demonstrated in cancer patients to improve quality of life (QoL) and physical fitness and to reduce fatigue. However, few PA programs have been proposed to TGCT patients and their effects on sequelae have not been assessed yet. A growing body of evidence links treatment-related alteration in the gut microbiota to sequelae of cancer survivors, including fatigue and cardiovascular toxicities. Also, PA has been known as a possible modulator of the gut microbiota composition. To date, no study has been conducted to examine how the gut microbiota and its metabolites moderate the effect of PA on fatigue and other late effects in TGCT survivors. The objectives will be to assess the impact of a PA program on fatigue and other sequelae and to investigate how the gut microbiota and its metabolites moderate the associations between PA and sequelae. We will conduct a prospective, multicenter, phase III, randomized controlled trial of a one-year supervised PA program. 236 men with metastatic TGCT and eligible for a first line of chemotherapy will be randomly assigned to either PA intervention or control arm. All patients will benefit from a connected activity tracker and PA recommendations. In the intervention arm, PA will be based on supervised sessions and motivational interviews. The primary endpoint (fatigue) will be assessed at 3 years. The trial will provide novel insights into the impact of PA on fatigue and other sequelae in TGCT survivors with understanding a potential underlying mechanism of gut microbiota. This evidence will support the development of targeted PA guidelines to improve QoL and reduce sequelae in TGCT survivors.",[614],"Metastatic Testicular Cancer",[616,617,618],"fatigue","sequelae","gut microbiota composition","2026-03-26",{"date":621,"type":38},"2026-03-31",{"date":623,"type":38},"2025-01-14",{"date":625,"type":22},"2038-01-14",{"name":44,"class":45},{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":55,"minAge":19,"maxAge":4,"enrollmentInfo":634,"targetDuration":4,"studyType":23,"phases":636,"briefSummary":637,"conditions":638,"keywords":641,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":645,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":135},"100468487","profiling-program-of-advancedmetastatic-pancreatic-cancer-patients-100468487","NCT05380414","Profiling Program of Advanced\u002FMetastatic Pancreatic Cancer Patients","A Single-center, Prospective Profiling Program of Advanced\u002FMetastatic Pancreatic Cancer Patients","Inclusion Criteria:\n\n* Male or female patient \\> 18 years\n* metastatic or advanced PDAC\n* Patient pretreated with no more than one prior systemic chemotherapy for metastatic\u002Fadvanced disease (radiotherapy is not counted as a line of therapy).\n* Availability of an archival representative FFPE tumor sample from primary tumor (surgery or diagnostic biopsy) and\u002For from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block.\n* Life expectancy \\> 3 months\n* PS score 0 or 1.\n\nExclusion Criteria:\n\n* Curative therapy available\n* Any condition contraindicated with blood sampling procedures required by the protocol.\n* Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer.\n* Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.",{"count":635,"type":22},750,[86],"The proposal is to implement a molecular screening program for advanced\u002Fmetastatic pancreatic cancer patients before the initiation of 1st line treatment in order to allow a better selection of patients for rationale personalized medicine with targeted agents and\u002For combination involving a chemotherapy backbone.",[639,640],"Metastatic Pancreatic Cancer","Advanced Pancreatic Cancer",[642,643,644],"Molecular screening","Genomic profiles","Transcriptomic profiles",{"date":621,"type":38},{"date":647,"type":38},"2022-07-01",{"date":649,"type":22},"2027-09-01",{"name":44,"class":45},{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":655,"acronym":656,"eligibilityCriteria":657,"healthyVolunteers":12,"sex":55,"minAge":658,"maxAge":114,"enrollmentInfo":659,"targetDuration":4,"studyType":286,"phases":4,"briefSummary":660,"conditions":661,"keywords":665,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":673,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":679,"locationsCount":135},"100630624","adaptation-strategies-for-coping-with-the-impact-of-sensory-alterations-on-eating-behavior-in-children-with-cancer-a-qualitative-study-from-the-perspective-of-children-and-parents-100630624","NCT07490093","Adaptation Strategies for Coping With the Impact of Sensory Alterations on Eating Behavior in Children With Cancer: A Qualitative Study From the Perspective of Children and Parents","QUALISENS","Inclusion Criteria:\n\nChildren:\n\n* Aged 6 to 17 years old on the day consent is obtained.\n* Diagnosed with a malignant hematological or oncological tumor.\n* Possessing sufficient verbal ability to participate in the interview planned for the study.\n* Having started chemotherapy treatment at least 2 months prior.\n* Agreeing to participate in the study.\n* Able to understand, read, and write French.\n* Affiliated with a social security system.\n\nParents:\n\n* Be the parent or legal guardian of a child aged 6 to 17 inclusive, with cancer and undergoing chemotherapy.\n* Dated and signed informed consent.\n* Able to understand, read, and write French.\n\nExclusion Criteria:\n\n\\-","6 Years",{"count":116,"type":22},"Childhood cancer is a serious and life-changing disease that affects thousands of children every year worldwide. In addition to the disease itself, cancer treatments such as chemotherapy often cause difficult side effects. Among these, changes in taste and smell are very common but still poorly understood in children. These sensory changes can make food taste unpleasant or smell different, leading children to eat less, avoid certain foods, or develop strong food aversions. As a result, many children with cancer experience weight loss, poor nutrition, and reduced quality of life, which can also affect how well they tolerate treatment.\n\nResearch suggests that between 40% and 60% of children with cancer struggle to maintain good nutritional status during treatment. Taste and smell alterations play a major role in these difficulties. Children may experience nausea triggered by food smells, changes in food texture perception, or a loss of pleasure in eating. Parents often report feeling powerless and lacking clear guidance on how to help their child cope with these problems.\n\nWhile taste and smell disturbances have been widely studied in adults with cancer, much less is known about how children experience these changes and, importantly, how they and their families adapt to them. Parents play a key role in supporting their child's eating habits, but their perspectives may differ from the child's own experiences.\n\nThis study aims to better understand how children undergoing chemotherapy and their parents perceive changes in taste, smell, and food texture, and how these changes affect eating behavior, emotions, and social life. Using individual semi-structured interviews, the study will explore the coping strategies used by children and parents to manage these sensory changes, both at home and in the hospital setting.\n\nBy giving children and parents a voice, this research seeks to identify practical, real-life strategies that families find helpful. The results will contribute to improving nutritional support and guidance for children with cancer, with the ultimate goal of enhancing their well-being, quality of life, and treatment outcomes.",[662,663,664],"Taste Alterations","Smell Disorder","Eating Behavior Changes",[125,666,667,668,669,670,671],"oncology","children","taste alterations","smell disorder","eating behaviour changes","coping strategies","2026-03-19",{"date":674,"type":38},"2026-03-24",{"date":676,"type":22},"2026-02",{"date":678,"type":22},"2026-10",{"name":44,"class":45},{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":684,"acronym":685,"eligibilityCriteria":686,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":687,"targetDuration":689,"studyType":286,"phases":4,"briefSummary":690,"conditions":691,"keywords":694,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":704,"lastUpdatePostDateStruct":705,"startDateStruct":707,"completionDateStruct":709,"leadSponsor":711,"locationsCount":74},"100585763","preoperative-magnetic-tracking-in-breast-surgery-in-france-french-medical-economic-study-100585763","NCT06906601","Preoperative Magnetic Tracking in Breast Surgery in France: French Medical-economic Study.","MAGNETO","Inclusion Criteria:\n\n* I1. Female aged ≥ 18 years;\n* I2. Patient presenting with a unifocal and unilateral lesion of invasive carcinoma or in situ;\n* I3. Indication for first breast-conserving treatment with the need for preoperative localization of the lesion, regardless of the associated lymph node procedure;\n* I4. Patient affiliated with a health insurance system;\n* I5. Non-opposition to the study.\n\nExclusion Criteria:\n\n* E.1. Psychological, family, or sociological condition that may potentially compromise adherence to the treatment protocol and follow-up;\n* E.2. Bilateral surgery required;\n* E.3. Patient with metastatic breast cancer;\n* E.4. Multifocal or benign lesions;\n* E.5. Pregnant or breastfeeding patient;\n* E.6. Need for neoadjuvant treatment;\n* E.8. Patient under guardianship, curatorship, or deprived of liberty.",{"count":688,"type":22},772,"6 Months","MAGNETO is a French medico-economic study on preoperative localization in breast cancer surgery. The main objective is to conduct a cost-consequence analysis comparing magnetic clip localization with the use of metallic wires for the preoperative identification of non-palpable breast lesions. The choice of localization method is left to the physician's and center's discretion. The study is non-interventional (with only questionnaires and data collection), prospective, and multicenter, with patient follow-up lasting up to six months after breast surgery.",[363,692,693],"Medico-economic Impact","Breast Cancer Surgery",[695,696,697,698,699,700,701,702,703],"cancer","breast cancer","breast cancer surgery","preoperative localization","magnetic clip","wire localization","health economic study","Cost-consequence analysis","medico-economic","2026-02-16",{"date":706,"type":38},"2026-02-17",{"date":708,"type":38},"2025-04-15",{"date":710,"type":22},"2027-10-15",{"name":44,"class":45},""]