[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Institut Claudius Regaud\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":685},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,45,71,104,126,149,174,201,231,258,292,322,348,376,400,424,451,476,505,529,555,579,607,633,661],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053648","evaluation-of-the-inflammation-based-index-as-a-predictive-marker-of-clinical-and-radiological-response-in-patients-treated-with-lu-177-oxodotreotide-for-intestinal-neuroendocrine-tumour-100053648",false,"NCT06876532","Evaluation of the Inflammation-based Index as a Predictive Marker of Clinical and Radiological Response in Patients Treated With Lu-177 Oxodotreotide for Intestinal Neuroendocrine Tumour","LUTIBI","Inclusion Criteria:\n\n1. Patient aged ≥ 18 years.\n2. Patient with histologically confirmed grade 1 or 2 neuroendocrine tumor of the midgut, inoperable or metastatic.\n3. Patient eligible for Lu-177 oxodotreotide therapy in accordance with its marketing authorization.\n4. Evidence of progression in the 12 months preceding Lu-177oxodotreotide therapy, confirmed by imaging techniques commonly used in current practice (thoraco-abdomino-pelvic CT and\u002For liver MRI, Ga-68 DOTA somatostatin analog PET-CT) +\u002F- liver involvement greater than 50%.\n5. Disease measurable according to RECIST 1.1 criteria in thoraco-abdomino-pelvic CT +\u002F- liver MRI.\n6. Patient affiliated to a social security scheme in France.\n7. Patient having signed informed consent prior to study inclusion and prior to any specific study procedure.\n\nExclusion Criteria:\n\n1. Previous treatment with Lu-177 oxodotreotide.\n2. Any contraindication to treatment with Lu-177 oxodotreotide.\n3. Morbid obesity (BMI \\> 40).\n4. Uncontrolled\u002Funbalanced active inflammatory disease in the 3 months prior to inclusion.\n5. Active carcinoid heart disease or other acute cardiovascular event.\n6. Active infection not treated within 15 days.\n7. Pregnant or breast-feeding woman.\n8. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and\u002For procedures stipulated in the study protocol.\n9. Patient deprived of liberty or under legal protection (guardianship, legal protection).","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, multicenter, open-label study designed to evaluate the specificity and sensitivity of the Inflammation Based Index (IBI) score as a marker for predicting clinical and radiological response in patients treated with Lu-177 oxodotreotide for inoperable or metastatic, progressive, grade 1 or 2 intestinal neuroendocrine tumors.\n\nThis IBI score will be assessed on the basis of C-reactive protein (CRP) and albumin values, and will be defined as follows:\n\n* IBI = 0: Low mortality risk (if CRP and serum albumin values are considered normal in the investigator's judgment).\n* IBI \\> 0, including: IBI = 1: Intermediate risk of mortality (if one of the two values is considered abnormal and clinically significant according to the investigator's judgment (either hypoalbuminemia or elevated CRP)); IBI = 2: High mortality risk (if both values are considered abnormal and clinically significant according to the investigator's judgment (hypoalbuminemia and elevated CRP)).\n\nPatients were followed up for 36 months.\n\nA total of 150 patients should be included in this study.",[27],"Intestinal Neuroendocrine Tumor",[27,29,30,31],"Lu-177 oxodotreotide","IBI score","Biomarker","RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":36},"2025-04-07",{"date":40,"type":21},"2031-04",{"name":42,"class":43},"Institut Claudius Regaud","OTHER",10,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100644333","analytical-validation-of-circulating-dna-analysis-methods-creation-of-a-control-cohort-100644333","NCT07663994","Analytical Validation of Circulating DNA Analysis Methods: Creation of a Control Cohort","HD-DNA","Inclusion Criteria:\n\n* 1 Adult volunteer (≥ 18 y.o.)\n* 2 Participant free of cancer\n* 3 Participant belonging to the personnel of Oncopole Claudius Regaud (IUCT-O) institution\n* 4 Participant affiliated to a Social Health Insurance in France\n* 5 Participant who received clear and understandable information about the research\n* 6 Participant who signed an informed consent form before inclusion into the study and before any study specific procedure\n* 7 Participant who accepts a blood draw in the context of the research\n* 8 Participant who agrees to be contacted in the event of an incidental finding of a potential genetic abnormality\n\nExclusion Criteria:\n\n* 1 Participant presenting with an associated pathology potentially preventing the adequate conduct of the study procedure\n* 2 Participant presenting with a contra-indication to blood draw\n* 3 Participant who reports to the investigator team\n* 4 Participant who has forfeited his\u002Fher freedom bu administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)",true,{"count":54,"type":21},68,[24],"Pilot, prospective, mono-center study conducted in a population of healthy participants (free of cancer) for the analytical validation of circulating DNA analysis methods. The participants are employees of the institution. Their recruitement is carried out via internal posting (intranet and bulletin boards). The study participation will be strictly voluntary and without consequences on the professional situation of the participants.",[58],"Healthy Volunteers (Cancer)",[60,61],"circulating DNA","liquid biopsy","2026-06-23",{"date":64,"type":36},"2026-06-26",{"date":66,"type":21},"2026-06-30",{"date":68,"type":21},"2026-07-31",{"name":42,"class":43},1,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":93,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":70},"100590480","research-of-double-positive-circulating-cells-tumor-marker--cd45-in-several-types-of-metastatic-cancers-100590480","NCT06967961","Research of Double-positive Circulating Cells (Tumor Marker \u002F CD45+) in Several Types of Metastatic Cancers","DP-PAN-CANCER","Inclusion Criteria:\n\n* 1\\. Patients with one of the following cancer types: urothelial carcinoma, renal carcinoma, prostate adenocarcinoma, upper aerodigestive tract carcinoma, cervival carcinoma, adenocarcinoma of endometrium, cutaneous melanoma, soft tissue sarcoma, seminomatous and nonseminomatous germ cell tumors\n* 2\\. Metastatic disease for which the treatment (whatever the line) has not been initiated yet\n* 3\\. Age ≥ 18 years\n* 4\\. Patient affiliated to a French Social Security scheme\n* 5\\. Patient having signed his\u002Fher informed consent prior to inclusion in the study and prior to any specific procedure for the study.\n\nExclusion Criteria:\n\n* 1\\. Patient with localized disease.\n* 2\\. Pregnant or breast-feeding women.\n* 3\\. Any psychological, family, geographical or sociological condition that prevents compliance with the medical monitoring and\u002For procedures set out in the study protocol.\n* 4\\. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).",{"count":79,"type":21},450,[24],"A prospective, proof-of-concept pilot study in patients with metastatic cancers (9 types of cancers are studied) treated at the IUCT-O or possibly in other institutions. Eligible patients will be selected and informed of this study during a medical consultation for their cancer by medical oncologists. Then, with the patient's consent and before the start of anti-cancer treatment (whatever the line), a blood sample will be taken to detect DP-circulating cells by 2 different methods of analysis.\n\nEach patient will participate in the study for one day. The methods of analysis will be: flow cytometry for all patients and either Parsotix® or CellSearch® depending on the type of cancer.\n\n450 patients will be enrolled in total.",[83,84,85,86,87,88,89,90,91,92],"Urothelial Carcinoma","Renal Cancer","Prostate Adenocarcinoma","Adenocarcinoma of Endometrium","Cutaneous Melanoma","Soft Tissue Sarcoma (STS)","Nonseminomatous Germ Cell Tumor","Seminomatous Germ Cell Tumor","Upper Aerodigestive Tract Carcinoma","Cervical Carcinoma",[94,95,61],"metastatic cancers","Double Positive Circulating cells","2026-06-12",{"date":98,"type":36},"2026-06-15",{"date":100,"type":36},"2025-07-23",{"date":102,"type":21},"2029-07-23",{"name":42,"class":43},{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":70},"100577341","proof-of-concept-to-assess-the-feasibility-of-a-decentralised-pathway-coordinated-by-the-advanced-practice-nurse-for-patients-receiving-oral-treatment-for-cancer-or-malignant-haemopathy-acceler-platform-100577341","NCT06797037","Proof of Concept to Assess the Feasibility of a Decentralised Pathway Coordinated by the Advanced Practice Nurse for Patients Receiving Oral Treatment for Cancer or Malignant Haemopathy (ACCELER PLATFORM)","Inclusion Criteria:\n\n1. Patient over 18.\n2. A patient with solid cancer or haematological malignancy receiving oral retroceded therapy as part of standard management.\n3. Patient with a performance index (ECOG): 0-2.\n4. Patient contactable by telephone for follow-up by the Advanced Practice Nurse.\n5. Patient willing to make two home visits within 6 months of inclusion.\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding patient.\n2. Any psychological, family, geographical or social condition which, in the judgement of the oncologist, could potentially prevent the collection of informed consent or hinder compliance with the study protocol.\n3. Patients deprived of their liberty by administrative or legal decision, or patients under guardianship.",{"count":111,"type":21},33,[24],"This is an open-label, single-centre, category 2 \"Jardé Law\" proof-of-concept study designed to demonstrate the feasibility of a decentralised care pathway for patients with cancer or haematological malignancies receiving oral treatment.\n\nThe study will be conducted on a population of 33 patients.\n\nIn current practice, patients with certain solid cancers or haematological malignancies may be prescribed oral chemotherapy on a retroceded basis. In these cases, the oncologist (coordinating investigator) sees the patient for a consultation every 3 cycles to prescribe\u002Frenew the treatment for approximately 3 months. Every month, the patient returns to the centre to have the treatment dispensed by the hospital pharmacy. No medical consultation is associated with this visit.\n\nIn this study, it is proposed to decentralise the delivery of treatment to these patients by introducing two visits to the patient's home by a service-providing nurse.\n\nThe decentralised patient pathway will be organised and monitored by the Advanced Practice Nurse (APN) at the investigating centre, who will be responsible in particular for coordination with the service-providing nurse and the hospital pharmacy.",[115,116],"Solid Cancer","Haematological Malignancies",[118],"Retroceded oral chemotherapy",{"date":120,"type":36},"2026-06-16",{"date":122,"type":36},"2025-05-19",{"date":124,"type":21},"2027-05-19",{"name":42,"class":43},{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":135,"phases":4,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":70},"100555843","acceptability-and-benefits-of-an-onco-sexology-program-for-laryngectomy-patients-and-their-partners-100555843","NCT06517355","Acceptability and Benefits of an Onco-sexology Program for Laryngectomy Patients and Their Partners","ABSENS","Inclusion Criteria:\n\nFor patients:\n\n1. Patient to be treated for ORL cancer by total (pharyngo)laryngectomy\n2. Patient WHO 0-1-2\n3. Age greater than or equal to 18 years\n4. Patient who has not objected to participation in the study.\n\nFor partners (if applicable) :\n\n1. Age greater than or equal to 18 years\n2. Subject who has not objected to participation in the study.\n\nExclusion Criteria:\n\nFor patients:\n\n1. Patient with another co-existing malignant disease at the time of inclusion.\n2. Any psychological, familial, geographical or sociological condition that does not allow for compliance with the medical follow-up and\u002For procedures foreseen in the study protocol.\n3. Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).\n\nFor partners (if applicable):\n\n1\\. Patients deprived of their liberty or under legal protection (guardianship and tutorship, safeguard of justice).",{"count":134,"type":21},45,"OBSERVATIONAL","Single-centre prospective pilot study designed to demonstrate the acceptability of onco-sexology management for laryngectomy patients and their partners in order to improve their perception of their intimate life. This is a non-interventional study (category 3 Loi Jardé), which will not result in any change in patient management. All procedures will be carried out in accordance with standard practice.\n\nPatients will be followed for 14 months.",[138],"ORL Cancer",[140,141,142],"ORL cancer","Onco-sexology care","Laryngectomy",{"date":120,"type":36},{"date":145,"type":36},"2024-07-30",{"date":147,"type":21},"2028-03",{"name":42,"class":43},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":158,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},"100325235","monitoring-of-immunological-mechanisms-and-biomarkers-underlying-efficacy-and-toxicity-of-cancer-immunotherapy-100325235","NCT03514368","Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy","MINER","Inclusion Criteria:\n\n1. Age ≥18 years at the time of study entry.\n2. Patient with histologically documented metastatic and\u002For unresectable solid malignant tumor (NSCLC, head and neck, melanoma (except uveal melanoma), bladder cancer or any other advanced solid tumor when I-O agent is expected to be efficient or when a clinical trial is an option).\n3. Patient for which a treatment with immune checkpoint blockade including, but not limited to, anti-PD-1, anti-PD-L1 and anti-CTLA-4 mAb alone or in combination has been decided.\n4. Archived tumor specimen available or feasible for pre-treatment tumor biopsy.\n5. Current treatment with ICB not yet started.\n6. Evaluable disease (measurable as per RECIST 1.1. or not).\n7. ECOG Performance status 0-2.\n8. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.\n9. Patient affiliated to a Social Health Insurance in France.\n\nExclusion Criteria:\n\n1. Patient pregnant, or breast-feeding.\n2. Uveal melanoma\n3. Any condition contraindicated with tumor \u002Fblood sampling procedures required by the protocol.\n4. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders.\n6. 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.\n7. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship.",{"count":157,"type":21},770,[24],"This is a translational, open-label, multi-site, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), in patients with multiple types of advanced (unresectable and\u002For metastatic) solid cancers.\n\nThe study will be conducted on a population of patients receiving ICB (anti-PD-1 or anti-PD-L1 or anti-CTLA4, alone or in combination) in the context of either routine care or a clinical study protocol.\n\nPatients with any of the following tumor types may be enrolled in the trial:\n\n* Non-Small Cell Lung Cancer (NSCLC),\n* Head and neck cancer,\n* Melanoma,\n* Bladder cancer,\n* Other tumor types when Immuno-Oncology agent is expected to be efficient or when a clinical trial is an option.\n\nFor each included patient, tumor biopsy specimens and blood samples will be collected at different time points.\n\nAll included patients will be followed-up until progression. After this date, survival data will be collected.",[161],"Solid Cancers",[163,164,165,166],"Immune checkpoint modulation","Tumor antigens","Adaptive immune responses","Tumor molecular signature",{"date":120,"type":36},{"date":169,"type":36},"2018-05-28",{"date":171,"type":21},"2029-11",{"name":42,"class":43},3,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":135,"phases":4,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":70},"100450916","multiomic-approach-to-radioresistance-of-ependymomas-in-children-and-adolescents-100450916","NCT05151718","Multiomic Approach to Radioresistance of Ependymomas in Children and Adolescents","Ependymomics: Multiomic Approach to Radioresistance of Ependymomas in Children and Adolescents","EPENDYMOMICS","Inclusion Criteria:\n\n* children with intracranial ependymoma\n* treated\n* included in PEPPI study, pediaRT or in SIOP II Ependymoma french program\n\nExclusion Criteria:\n\n* NA","25 Years",{"count":184,"type":21},370,"Treatment of childhood ependymoma, the second most frequent pediatric brain tumor, is based on surgery and radiation therapy. However, 50% relapse, mainly locally. Progress in imaging, molecular biology and radiotherapy ballistics has led us to propose the EPENDYMOMICS project, a multi-omics approach using artificial intelligence to detect the predictive characteristics of relapse, and to define innovative radiotherapy targets using multimodal imaging. We previously reported that the relapse sites are mainly located in the high-dose radiotherapy zone and that there appear to be prognostic factors for relapse based on anatomical and functional MRI abnormalities by diffusion and perfusion. In addition, recent studies in molecular biology have identified significant prognostic factors. The challenge now is to use and correlate all these findings in larger cohorts to tackle the radio-resistance of this disease.\n\nOur objective is to collate in a single database called NETSPARE (Network to Structure and Share Pediatric data to Accelerate Research on Ependymoma) the clinical, histological, biological, imaging and radiotherapy data from two consecutive studies that included 370 children and adolescents with ependymoma since 2000 in France. The EPENDYMOMICS project will comprise a clinical research team, three imaging research teams, two histopathology teams, and a biostatistics team working on NETSPARE. Our goal is to obtain a radiogenomic signature of our data, which will be validated with the English external cohort of 200 patients that is currently being analyzed. The perspective is to optimize the indications and volumes of irradiation that could in the future be used in a European translational research trial to tackle radioresistance.",[187,188],"Ependymoma of Brain","Pediatric Solid Tumor",[190,191,192],"childhood ependymoma","radio-resistance","radiogenomic signature","2026-06-02",{"date":195,"type":36},"2026-06-04",{"date":197,"type":36},"2021-09-30",{"date":199,"type":21},"2026-09-30",{"name":42,"class":43},{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":209,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100517793","phase-2-a-study-to-evaluate-pre-operative-hypofractionated-radiation-therapy-in-aged--70-years-old-or-fragile--65-years-patients-with-limb-or-trunk-soft-tissue-sarcoma-100517793","NCT06022159","A Study to Evaluate Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or \"Fragile\" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.","Phase II Study Evaluating Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years) or \"Fragile\" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.","HYPOSARC","Inclusion Criteria:\n\n1. Patient with histologically confirmed soft tissue sarcoma of the limbs or trunk.\n2. Indication for neo-adjuvant or adjuvant radiotherapy.\n3. Patient aged ≥ 70 years with a performance status ECOG ≤ 2 and\u002For aged 65 to 70 years with an ECOG of 2 and identified by the investigator as \"fragile\".\n4. Patient affiliated to a Social Health Insurance in France.\n5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures.\n\nExclusion Criteria:\n\n1. Retroperitoneal, ORL and visceral sarcomas.\n2. Previous radiotherapy in the area.\n3. Metastatic disease.\n4. Concomitant or sequential chemotherapy.\n5. Patient requiring total surgery (amputation).\n6. Other cancer under treatment.\n7. Any condition or pathology contraindicating MRI.\n8. Any psychological, familial, geographic or social situation, potentially preventing the provision of informed consent or compliance to study procedure.\n9. Patients included in another therapeutic interventional trial.\n10. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).","65 Years",{"count":211,"type":21},48,[213],"PHASE2","This is a phase II, multicenter, non-randomized study.\n\nThe main objective is to evaluate the treatment with hypofractionated radiation therapy in neo-adjuvant situations on wound healing in a population of aged patients (≥ 70 years old) or ≥ 65 years of age defined as \"fragile\" and treated for soft tissue sarcoma.\n\nA maximum of 48 evaluable patients will be included in this study. The patients will receive an hypofractionated radiation therapy prior to conservative surgery.\n\nEach patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery).",[216],"Soft Tissue Sarcoma",[216,218,219,220,221,222],"Limb soft tissue SARComa","Trunk soft tissue SARComa","Aged population","\"Fragile\" population","hypofractionated radiation therapy","2026-05-29",{"date":193,"type":36},{"date":226,"type":36},"2023-11-28",{"date":228,"type":21},"2029-05",{"name":42,"class":43},11,{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":245,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":70},"100585612","comparison-of-different-methods-of-capture-of-circulating-tumour-cells-ctc-in-patients-with-metastatic-breast-or-prostate-cancer-100585612","NCT06904625","Comparison of Different Methods of CAPTure of Circulating Tumour Cells (CTC) in Patients With Metastatic Breast or Prostate Cancer","CAPT CTC","Inclusion Criteria:\n\n1. Patient with breast cancer (whatever the immunohistochemical subtype: triple-negative, RH+\u002FHER2-negative or HER2-positive) or prostate cancer, multi-metastatic, eligible for a new line of treatment.\n2. Patient not yet initiated on a new specific treatment for breast or prostate cancer at inclusion.\n3. Age ≥ 18 years and WHO ≤ 2\n4. Patient affiliated to Social Security scheme in France.\n5. Patient having signed informed consent prior to inclusion in the study and prior to any study-specific procedures.\n\nExclusion Criteria:\n\n1. Associated pathology(ies) likely to prevent the study procedure from running smoothly\n2. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and\u002For procedures stipulated in the study protocol.\n3. Patient deprived of liberty or under legal protection (guardianship, legal protection)\n4. Patient who has had another solid tumor (excluding carcinoma in situ of the breast or cervix) within 5 years.",{"count":239,"type":21},54,[24],"This trial is a pilot, prospective, single-center study conducted in a population of patients with metastatic breast cancer (whatever the immunohistochemical subtype) or metastatic prostate cancer. The aim of this exploratory study is to compare the sensitivity of three different techniques (CellSearch®, Parsortix® and SmartCatch®) in detecting circulating tumor cells (CTCs). After the patient's agreement, and before starting anti-tumor treatment, a blood sample will be taken using the 3 different CTC detection techniques.\n\nEach patient will participate in the study for one day.\n\nA total of 54 evaluable patients (36 patients with metastatic breast cancer and 18 patients with metastatic prostate cancer) will be included in this interventional study.",[243,244],"Metastatic Breast Cancer","Metastatic Prostate Cancer",[246,244,243,247,248,249],"Circulating Tumor Cell","CellSearch®","Parsortix®","SmartCatch®","2026-05-22",{"date":252,"type":36},"2026-05-27",{"date":254,"type":36},"2025-08-14",{"date":256,"type":21},"2026-11",{"name":42,"class":43},{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":265,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":270,"conditions":271,"keywords":274,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":291},"100483906","phase-3-para-aortic-lymphadenectomy-in-locally-advanced-cervical-cancer-100483906","NCT05581121","PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer","PAROLA","Inclusion Criteria:\n\n1. Age ≥ 18 years at time of study entry\n2. Newly diagnosed histologically proven cervical squamous carcinoma, adenocarcinoma, or adenosquamous tumor\n3. FIGO stage IIIC1 (FIGO 2018) cervical cancer with FDG-PET\u002FCT showing FDG-positive pelvic nodes and FDG-negative PALN including equivocal lymph nodes in the common iliac and para-aortic regions. The highest positive lymph node must be located inferior to the common iliac bifurcation in both sides (anatomical level 1).\n4. Patients with TNM T stage I-IIIB.\n5. FIGO stage IIIC1 cervical cancer by positive pelvic sentinel lymph node from surgical staging (either intraoperative assessment (frozen section) or from final histology - patients are not eligible after radical hysterectomy, and FDG-negative common iliac of para-aortic lymph node on PET\u002FCT (performed before or after SLN procedure)\n6. Patient eligible for pelvic radiotherapy and cisplatin-based chemotherapy with a curative intent as confirmed by a multidisciplinary board\n7. ECOG performance status \\\u003C 2 i.e. 0 or 1\n8. Life expectancy more than 12 months\n9. Pretherapeutic imaging FDG-PET\u002FCT images should be available for central review\n10. Prior validation of the surgeon's participation in the study by the Quality Assurance Comity\n11. Women should be post-menopaused or willing to accept the use of an effective contraceptive regimen during the treatment period. All non-menopaused women should have a negative pregnancy test within 72 hours prior to study entry.\n12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n13. Not applicable since protocol revision V4. Patient participating to other clinical trials including immunotherapy strategies or adjuvant chemotherapy is also eligible for the study. Adjuvant treatment must be decided prior to randomization\n14. Signed informed consent\n15. Patient affiliated to a Social Health Insurance in France (French patients only).\n\nExclusion Criteria:\n\n1. Unequivocal positive common iliac or para-aortic lymph nodes at pretherapeutic imaging FDG-PET\u002FCT\n2. Negative or equivocal pelvic lymph nodes at pretherapeutic imaging FDG-PET\u002FCT\n3. Metastatic disease confirmed by FDG-PET\u002FCT\n4. Other histologies than adenocarcinoma, squamous cell carcinoma and adenosquamous carcinoma\n5. Contraindication for cisplatin-based chemotherapy\n6. Women who received any prior treatment for cervical cancer\n7. Prior surgery for the cervical cancer, except for cone procedure and pelvic lymph node staging\n8. Previous pelvic radiotherapy\n9. History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease after 5 years, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ (any location) without evidence of disease.\n10. 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\n11. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).","FEMALE",{"count":267,"type":21},510,[269],"PHASE3","This is an international, multicenter and randomized open-label phase III study designed to demonstrate, in patients with stage IIIC1 cervical cancer, whether para-aortic lymphadenectomy followed by tailored chemoradiation is associated with increased disease-free survival compared to patients staged with FDG-PET\u002FCT only followed by chemoradiation.\n\nThe planned sample size is 510; including 200 patients in France.\n\nIn this trial, patients will be assigned in one of the two following treatments arms:\n\n* Arm A (control arm): Standard chemo-radiotherapy and brachytherapy according to EMBRACE II and ESGO\u002FESTRO recommendations.\n* Arm B (experimental arm): Pretherapeutic para-aortic lymphadenectomy followed by tailored chemo-radiotherapy and brachytherapy.\n\nConsidering the changing standard treatment landscape of locally advanced cervical cancer, both arms (control arm and experimental arm) may also be treated according to the INTERLACE and KEYNOTE-A18 studies, if applicable, at the discretion of the attending physician.\n\nEach patient will be followed up for 5 years.\n\nA cost-utility study will be performed in patients included in France. Other countries could be involved in this specific study. It will assess the incremental cost-utility ratio (cost per QALY gained) of para-aortic lymphadenectomy followed by tailored chemo-radiation in patients with positive PALN compared to patients staged with PET\u002FCT only followed by chemo-radiation.\n\nThis study also has ancillary objectives:\n\n* Biologic: To study T cell exhaustion, immune changes during chemoradiation, HPV ctDNA dynamic evolution, and the par-aortic lymph node as a premetastatic niche.\n* Radiomics: To study the contribution of radiomics and FDG-PET\u002FCT metabolic parameters to predict para-aortic lymph node involvement and clinical outcome.\n* Senti-PAROLA: To evaluate the accuracy (Sensitivity, specificity, positive and negative predictive value) of the para-aortic sentinel lymph node (SPA) for PALN staging, and to evaluate the prognostic value of low volume metastasis of SPA.",[92,272,273],"Adenocarcinoma","Adenosquamous Carcinoma",[275,276,277,278,279,280,281,282],"Locally advanced cervical cancer","HPV 16+","Stage IIIC1","Radiation therapy","Cisplatin","Para-aortic lymphadenectomy","INTERLACE","KEYNOTE-A18","2026-05-21",{"date":285,"type":36},"2026-05-26",{"date":287,"type":36},"2023-12-20",{"date":289,"type":21},"2033-12-20",{"name":42,"class":43},35,{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":302,"briefSummary":304,"conditions":305,"keywords":307,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":230},"100607960","phase-4-study-aiming-to-compare-the-plasma-exposure-of-the-payload-free-dxd-in-patients-treated-by-t-dxd-for-locally-advanced-or-metastatic-breast-cancer-according-to-their-bmi-100607960","NCT07195344","Study Aiming to Compare the Plasma Exposure of the Payload (Free-DXd) in Patients Treated by T-DXd for Locally Advanced or Metastatic Breast Cancer According to Their BMI.","Influence of Patient's Morphological Characteristics on Pharmacokinetic and Toxicity of Trastuzumab-Deruxtecan Administered for Metastatic Breast Cancers","TDXdose","Inclusion Criteria:\n\n1. Women (or men) aged ≥ 18 years on the day of signing the informed consent with histologically proven breast cancer.\n2. Metastatic or locally advanced breast cancer with overexpression\u002Famplification HER2 (IHC +++ or ++ and positive-hybridation in situ) or low HER2 expression (IHC + or ++ and negative-hybridation in situ) and may be ultra-low (in first line, in case of approval).\n3. Patient eligible for Trastuzumab-Deruxtecan (T-DXd).\n4. Concomitant administration of pertuzumab may be accepted in case of approval in first line for HER2- overexpressed\u002Famplified locally advanced or metastatic breast cancer.\n5. Female subjects of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study treatment.\n6. Female subjects of childbearing potential must be willing to follow at least one method of contraception or be surgically sterile, or abstain from heterosexual activity for the duration of the study and until 7 months after the last dose of study treatment. Subjects of childbearing potential are those who have not been surgically sterilized and who had menstruation in the last 12 months.\n\n   Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception.\n7. Male subjects must agree to use at least one method of contraception for the duration of the study and until 4 months after the last dose of study treatment.\n\n   Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception.\n8. Signed written informed consent.\n9. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol.\n10. Patient affiliated to a Social Health Insurance in France.\n\nExclusion Criteria:\n\n1. Peripheral venous access making blood samples difficult.\n2. Patients unable to receive T-DXd treatment at a dose of 5.4 mg\u002Fkg in cycle 1 (whatever the reason)\n3. Patients with known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n4. Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.\n5. Patient pregnant, or breast-feeding.\n6. 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.\n7. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).\n8. Concurrent participation in an experimental drug study.\n9. Patient with a known history of hypersensitivity to the active substance of T-DXd or to any of the excipients listed in the SmPC of T-DXd.\n10. Patient with severe hepatic impairment defined by TGO and\u002For TGP \\> 5 x ULN and Total bilirubin \\> 1.5 x ULN.",{"count":301,"type":21},210,[303],"PHASE4","This is a multicenter, prospective, non-randomized, open-label, pharmacokinetic study, aiming to compare the plasma exposure of the payload (free-DXd) in patients treated by T-DXd for locally advanced or metastatic breast cancer according to their BMI.\n\nThe primary objective is to compare plasma exposition of the payload (free-DXd) between overweight or obese (BMI\\>25) and normal weight (BMI≤25) breast cancer patients during the first 3 cycles of Trastuzumab-Deruxtecan (T-DXd).\n\nA total of 210 patients will have to be enrolled in this study with the following repartition:\n\nN = 105 patients with a BMI ≤ 25 (normal weight patients). N = 105 patients with a BMI \\> 25 (overweight or obese patients) with at least 30 obese patients (BMI\\>30).",[306],"Locally Advanced or Metastatic Breast Cancers",[308,309,310,311,312,313],"Locally or metastatic Breast Cancer","HER2 low-expressed","HER2 over-expressed\u002Famplified","Trastuzumab-Deruxtecan","Body Mass Index","Pharmacokinetics","2026-04-29",{"date":316,"type":36},"2026-05-05",{"date":318,"type":36},"2025-10-15",{"date":320,"type":21},"2029-10",{"name":42,"class":43},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":329,"minAge":330,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":22,"phases":333,"briefSummary":334,"conditions":335,"keywords":337,"overallStatus":340,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":345,"leadSponsor":347,"locationsCount":70},"100635873","male-breast-cancer-predisposition-factor-creation-of-a-control-cohort-2-100635873","NCT07558343","Male breAsT cAncer preDisposition Factor: Creation of a Control Cohort 2","MATADOR2","Inclusion Criteria:\n\n* 1\\. A male volunteer participant with no personal history of cancer, registered in the IUCT-O oncogenetics database as a relative of a patient carrying a pathogenic or likely pathogenic variant in one of the cancer predisposition genes routinely analyzed at the oncogenetics laboratory\n* 2\\. Age ≥ 66 years\n* 3\\. Participant with no known family relationship to a patient of the MATADOR1 cohort\n* 4\\. Participant who has undergone an oncogenetic consultation at the IUCT-O\n* 5\\. Participant who does not carry the familial mutation in any of the cancer predisposition genes previously tested\n* 6\\. Participant for which an archived blood sample is available for the research in the oncogenetics laboratory\n* 7\\. Participant having signed an informed consent form before inclusion in the study and before any study specific procedure\n\nExclusion Criteria:\n\n* 1\\. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).","MALE","66 Years",{"count":332,"type":21},120,[24],"This is an interventional, prospective, single-center study designed to collect and describe genetic, environmental and psychosocial control data from male participants. The participants did not have any prior history of cancer at the time of the oncogenetic consultation and do not have the family mutation researched during the oncogenetic consultation (targeted genetic testing). The participants are referenced in the IUCT-O medical records as family members of patients suffering from male breast cancer.\n\nThe study will be conducted on a population of 120 participants.",[336],"Male Breast Cancer",[338,339],"breast cancer","predisposition factor","NOT_YET_RECRUITING","2026-04-23",{"date":343,"type":36},"2026-04-30",{"date":98,"type":21},{"date":346,"type":21},"2027-07-15",{"name":42,"class":43},{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":265,"minAge":356,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":22,"phases":359,"briefSummary":360,"conditions":361,"keywords":363,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":70},"100419359","study-to-evaluate-the-impact-of-the-use-of-alternative-and-complementary-therapies-on-therapeutic-adherence-in-patients-treated-with-tamoxifen-for-early-stage-breast-cancer-100419359","NCT04740697","Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer","Pilot Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer","EUTACAM","Inclusion Criteria:\n\n1. Age ≥ 18 years at entry into the study.\n2. Patient treated for hormone-dependent localized breast cancer requiring adjuvant Hormonal Therapy (HT) with tamoxifen.\n3. Patients treated with tamoxifen for a maximum of 1 to 3 years.\n4. Patient affiliated with a Social Security system in France.\n5. Patients who signed informed consent prior to inclusion in the study and prior to any specific study procedures.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. Any psychological, family, geographical or sociological condition that does not allow the medical follow-up and\u002For the procedures foreseen in the study protocol to be respected.\n3. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).","18 Months",{"count":358,"type":21},200,[24],"This is a pilot, prospective, interventional, monocentric study designed to evaluate, in a real-life situation, adherence to tamoxifen treatment as a function of the taking of alternative and complementary therapies in patients with localized hormone-dependent breast cancer.\n\n200 patients will be included in the study.\n\nEach patient will be followed for one day.",[362],"Breast Cancer",[362,364,365,366,367],"Tamoxifen","Alternative and complementary therapies","Treatment adherence","Turmeric","2026-04-17",{"date":370,"type":36},"2026-04-20",{"date":372,"type":36},"2021-02-12",{"date":374,"type":21},"2028-02",{"name":42,"class":43},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":389,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":70},"100401914","phase-2-interest-of-medical-hypnosis-in-anxious-patients-treated-by-radiotherapy-100401914","NCT04513444","Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy","Phase II Study Aiming to Evaluate the Interest of Medical Hypnosis in Anxious Patients Treated by Radiotherapy","HYPNOMUSE","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of enrollment into the study.\n2. Patient with localized or metastatic solid malignant tumor.\n3. Patient being followed for the cancer pathology at IUCT-O and to receive, for the first time in the follow-up, treatment by radiotherapy (radiotherapy treatment should not have been initiated prior to inclusion in the study).\n4. Patient for whom radiotherapy treatment includes at least 15 sessions of radiation therapy.\n5. Patient defined as moderately anxious, anxious or very anxious after completing the STAI-Y self-assessment questionnaire (i.e. ≥ 46 score at inclusion).\n6. ECOG patient ≤ 2.\n7. Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.\n8. Patient affiliated to a Social Health Insurance in France.\n\nExclusion Criteria:\n\n1. Patient doesn't understand the French language.\n2. Patient with psychiatric disorders requiring antidepressant or antipsychotic treatment.\n3. Patient with hearing problems.\n4. Pregnant or breastfeeding women.\n5. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and\u002For procedures of the study protocol.\n6. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).",{"count":134,"type":21},[213],"This phase II, randomized, non-comparative and monocentric study aims to evaluate the interest of medical hypnosis in the management of anxiety in patients who are moderately anxious, anxious or very anxious during their radiotherapy treatment.\n\n45 patients will be randomized into the following arms:\n\n* Arm A (standard): relaxation with music listening during radiotherapy treatment\n* Arm B (experimental): relaxation with music listening and hypnosis during radiotherapy treatment\n\nFor the study each patient will be followed during 2 months.",[388],"Solid Tumor",[388,390,391,392,393],"Radiotherapy","Hypnosis","Anxiety","Music listening",{"date":370,"type":36},{"date":396,"type":36},"2020-12-07",{"date":398,"type":21},"2027-08",{"name":42,"class":43},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":412,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":423},"100386096","phase-3-interest-of-peri-operative-chemotherapy-in-patients-with-cinsarc-high-risk-localized-soft-tissue-sarcoma-100386096","NCT04307277","Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma","CHIC-STS01","Inclusion Criteria:\n\n1. Diagnosis of soft-tissue sarcoma, histologically confirmed by RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network\n2. According to FNCLCC grading system, grade 1, 2 or 3 tumors\n3. Resectable and localized disease after appropriate extension work-up (including at least a chest-CT)\n4. 6 weeks or less between surgical excision and inclusion (if performed before inclusion)\n5. Available archived FFPE tumor sample in sufficient quantity to allow CINSARC qualification\n6. Age ≥ 18 years\n7. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n8. Life expectancy of at least 12 weeks after the start of the treatment\n9. Women should be post-menopaused or willing to accept the use of an effective contraceptive regimen during the treatment period and at least 12 months (ifosfamide treatment) or 6 months (dacarbazine treatment) after the end of the treatment period. All non-menopaused women should have a negative pregnancy test within 72 hours prior to registration. Men should accept to use an effective contraception during treatment period and at least 3 months after the end of the study treatment.\n10. Signed written informed consent\n11. Patient affiliated to a Social Health Insurance in France.\n\nExclusion Criteria:\n\n1. Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcomas, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, epithelioid sarcoma, alveolar or embryonal rhabdomyosarcoma\n2. Primitive cutaneous, retroperitoneal, uterus or visceral STS\n3. Metastatic disease\n4. Previous or ongoing treatment for the sarcoma (with the exception of surgical excision)\n5. Contra-indication for Doxorubicin, Ifosfamide and Dacarbazine treatments\n6. Prior therapy with ifosfamide or cyclophosphamide or other nitrogen mustards, and prior therapy with anthracyclines\n7. Prior mediastinal\u002Fcardiac radiotherapy\n8. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia, myocardial infarction within 6 months prior to study entry\n9. Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma\n10. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy\n11. Known infection with HIV, hepatitis B, or hepatitis C\n12. Women who are breastfeeding, pregnant or who plan to become pregnant while in the trial\n13. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study\n14. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)\n15. Patient unable to comply with the protocol for any reason.\n\nADDITIONAL CRITERIA FOR THE RANDOMIZED PHASE III STUDY\n\n1. High-risk CINSARC signature\n2. Acceptable hematologic function (within 72 hours prior randomization): Absolute neutrophil count (ANC) ≥ 1.5 G\u002FL, Platelet count ≥ 100 G\u002FL and Hemoglobin \\> 9g\u002FdL\n3. Acceptable renal function within 72 hours prior randomization: Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL\u002Fmin (by the Cockcroft and Gault formula)\n4. Acceptable liver function: Bilirubin ≤ 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN\n5. Normal LVEF (\\>50%) measured by echocardiography or isotopic ventriculography",{"count":408,"type":21},600,[269],"Phase III, multicenter, randomized open-label and comparative study designed to demonstrate whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves metastasis-free survival as compared with standard management in patients with resectable STS, considered as high-risk according to CINSARC (Complexity Index in SARComas) signature.\n\nAfter signed informed consent, patients considered as eligible to CHIC-STS study by the investigator will be enrolled in the study and a molecular screening will be performed (600 patients will be screened).\n\nPatients considered as low-risk according to CINSARC signature will be treated at the discretion of the clinicians (prospective cohort).\n\nPatients considered as high-risk according to CINSARC signature will be randomized in the open-label multicenter phase III trial and assigned in one of the two following treatments arms:\n\n* Arm A (control arm): Standard of care (surgical excision +\u002F- external radiotherapy).\n* Arm B (experimental arm): Standard of care + 4 cycles of intravenous chemotherapy during 12 weeks.\n\nA total of 250 patients will have to be randomized with 125 patients in each arm.",[216],[216,413,414],"CINSARC signature","Chemotherapy","2026-04-09",{"date":417,"type":36},"2026-04-14",{"date":419,"type":36},"2020-10-09",{"date":421,"type":21},"2032-10",{"name":42,"class":43},19,{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":17,"minAge":431,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":22,"phases":435,"briefSummary":436,"conditions":437,"keywords":439,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":450},"100562185","irradiation-in-paediatrics-neurocognition-neuroimaging-and-evaluation-of-memory-and-attention-100562185","NCT06599879","Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention","IPANEMA","Inclusion Criteria:\n\n1. Patient who has received localised brain irradiation or craniospinal irradiation for a brain tumour whose treatment includes first-line radiotherapy.\n2. Patient with one of the following tumour types: ependymomas, medulloblastomas, malignant germ cell tumours, craniopharyngioma, pinealoblastoma.\n3. Patient aged between 4 and 12 years at the time of radiotherapy treatment.\n4. End of irradiation within 2 years (+\u002F-3 months) prior to inclusion.\n5. Patient having been treated by photontherapy or proton therapy.\n6. Sufficient visual, auditory (with authorised hearing aid) and oral or written expression capacity to carry out the neuropsychological tests properly.\n7. Proficiency in the French language by the patient and parent(s).\n8. Patient affiliated to a Social Security scheme in France.\n9. Informed consent signed by the patient\u002Flegal parent(s)\u002Fguardian(s) in accordance with French law and Good Clinical Practice.\n\nExclusion Criteria:\n\n1. Patient presenting with severe ataxia.\n2. Patient with a recurrence of the disease.\n3. Not applicable since protocol version 2. Metastatic patient.\n4. Any contraindication to MRI for patients included in Toulouse (i.e. in particular patients with a pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, patients with haemostatic clips on intracerebral aneurysms, patients with orthopaedic implants, claustrophobic patients).\n5. Patients undergoing psychostimulant or psychotropic treatment (in particular methylphenidate, antidepressants).\n6. Any psychological, family, geographical or sociological condition that prevents compliance with medical monitoring and\u002For the procedures set out in the study protocol.\n7. Patients deprived of their liberty or under legal protection.\n8. Severe posterior fossa syndrome with akinetic mutism.","6 Years","14 Years",{"count":434,"type":21},130,[24],"This is a prospective, open-label, multicentric study designed to correlate the dose delivered to the hippocampus with declarative memory deficits 2 years after radiotherapy treatment in a paediatric population who had received brain irradiation between the ages of 4 and 12 for a brain tumour.\n\nIn order to meet this objective, several neuropsychological assessments consisting of parental questionnaires and cognitive tests will be carried out during the course of the study, at the following two stages:\n\n* A 1st assessment at patient inclusion, i.e. 2 years after the end of radiotherapy treatment,\n* And a second assessment 2 years after patient inclusion, i.e. 4 years after the end of radiotherapy treatment.\n\nA retrospective assessment of the patient's neurocognitive level 1 year before the diagnosis of the disease will also be carried out at inclusion, with the parents completing a questionnaire specifically designed for the trial.\n\nIn addition, patients who have received their radiotherapy treatment at the IUCT-O will be offered participation in the ancillary imaging study. If the parents and the patient agree, multimodal MRI scans specific to the study (without injection of contrast) will be performed at inclusion and 2 years after inclusion.\n\nImaging and radiotherapy data will be collected in parallel using the PediaRT software used in current practice (collection of radiotherapy dosimetric data as well as standard MRI examinations pre-operatively, post-operatively, and at the 2-year and 4-year follow-up).\n\n130 patients will be included in this study.",[438],"Brain Tumor, Pediatric",[438,390,440,441],"Neurocognitive sequelae","Imaging","2026-04-08",{"date":444,"type":36},"2026-04-13",{"date":446,"type":36},"2025-10-21",{"date":448,"type":21},"2030-10",{"name":42,"class":43},15,{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":22,"phases":459,"briefSummary":460,"conditions":461,"keywords":462,"overallStatus":340,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":173},"100625788","monitoring-of-immunological-mechanisms-and-biomarkers-underlying-efficacy-of-immunotherapy-in-patients-with-early-stage-cancer-100625788","NCT07427186","Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy of Immunotherapy in Patients With Early Stage Cancer","MINER2","* Inclusion Criteria:\n\n  1. Age ≥18 years at the time of study entry.\n  2. Patient with histologically documented early stage solid malignant tumor (NSCLC, head and neck cancer, melanoma (except uveal melanoma), bladder cancer or any other early stage solid tumor when I-O agent is expected to be efficient in a neo-adjuvant setting (whether in standard of care or within a clinical trial).\n  3. Patient for whom a neo-adjuvant treatment with immune checkpoint blockade including, but not limited to, anti-PD-1, anti-PD-L1 and anti-CTLA-4 mAb alone or in combination with chemotherapy or other therapies has been decided.\n  4. Availability of an archived tumor specimen (block FFPE) sampled prior to the start of the treatment.\n  5. Treatment with ICB not yet started.\n  6. ECOG Performance status 0-2.\n  7. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.\n  8. Patient affiliated to a Social Health Insurance in France.\n* Exclusion Criteria:\n\n  1. Patient pregnant, or breast-feeding.\n  2. Uveal melanoma\n  3. Any condition contraindicated with tumor \u002Fblood sampling procedures required by the protocol.\n  4. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n  5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders.\n  6. 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.\n  7. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship.",{"count":408,"type":21},[24],"This is a translational, multicentric, prospective cohort study aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), and investigate the immunological dynamics associated with neo-adjuvant immunotherapy in patients with multiple types of early stage solid cancers treated with ICB ± chemotherapy or other therapies, prior to surgery (and after surgery if adjuvant ICB treatment is also administered). Patients with any of the following tumor types may be enrolled in the trial:\n\nNon-Small Cell Lung Cancer (NSCLC), Head and neck cancer, Melanoma, Bladder cancer, Other tumor types when Immuno-Oncology agent is expected to be efficient in a neo-adjuvant setting (whether in standard of care or within a clinical trial).\n\nFor each included patient, blood samples will be collected at different time points. Tumor samples will be made available for the research however, no biopsy will be performed specifically for this study.\n\nAll included patients will be followed up for 5 years after baseline.",[161],[463,464,465,466,467],"Immunotherapy","tumor microenvironment","adaptive immune responses","Immune checkpoint blockade","tumor antigens","2026-02-23",{"date":470,"type":36},"2026-02-25",{"date":472,"type":21},"2026-04-15",{"date":474,"type":21},"2041-04-15",{"name":42,"class":43},{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":22,"phases":485,"briefSummary":486,"conditions":487,"keywords":488,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":7},"100468317","study-evaluating-dna-double-strand-breaks-dsbs-repair-factors-polq-shieldin-complex-and-53bp1-expression-as-biomarker-of-parp-inhibitor-resistance-in-patients-with-deleterious-germline-mutation-in-brca-12-and-her2-negative-metastatic-or-locally-advanced-breast-cancer-100468317","NCT05378204","Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1) Expression as Biomarker of PARP Inhibitor Resistance in Patients With Deleterious Germline Mutation in BRCA 1\u002F2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer.","Prospective and Multicentric Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1) Expression as Biomarker of PARP Inhibitor Resistance in Patients With Deleterious Germline Mutation in BRCA 1\u002F2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer.","REPARP","MAIN STUDY\n\nINCLUSION CRITERIA:\n\n1. Women (or men) aged ≥ 18 years with histologically proven breast cancer\n2. Metastatic relapse or locally advanced breast cancer\n3. No-HER2 overexpression or amplification\n4. Triple-negative (defines as ER\\\u003C1%, PR\\\u003C1% and HER2-negative as per ASCO CAP guidelines) or hormone receptor positive (defines as ER and\u002For PR ≥ 1%) breast cancer\n5. Patients with metastases that can be biopsied except bone metastases. At baseline, if patients already have an archived biopsy from a secondary or a primary site (if stage IV) of their current disease, this material can be used for the study, provided that, it was collected within 3 months prior enrollment and a frozen and a FFPE sample are both available for research\n6. ECOG Performance Status ≤ 2\n7. Patients must have measurable or evaluable disease according to RECIST v1.1\n8. Patient with deleterious germline BRCA 1 and\u002For 2 mutation, eligible for PARP inhibitor therapy (olaparib or talazoparib), according each investigator\n9. Any number of prior lines therapy are allowed\n10. Current treatment with PARP inhibitor not yet started\n11. Women should be post-menopaused or willing to accept the use of an effective contraceptive regimen during the treatment period by PARP inhibitor\n12. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol\n13. Patient affiliated to a Social Health Insurance in France\n\nNON-INCLUSION CRITERIA:\n\n1. Abnormal coagulation contraindicating biopsy\n2. Bone metastases when this is the only site of biopsiable disease\n3. Patients with all target in a previously irradiated region, except if clear progression has been observed prior to study in at least one of them\n4. Patients with known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer\n5. Patients with known untreated CNS metastases and\u002For carcinomatous meningitis\n6. Patients with a known history of Human Immunodeficiency Virus (HIV)\n7. Patients with known active Hepatitis B or C\n8. Patients should not be on any other anti-cancer therapy (chemotherapy, endocrine therapy, immunotherapy, tailored therapy or alternative investigational therapy)\n9. Patient pregnant, or breast-feeding\n10. 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\n11. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)\n\nSUB-STUDY\n\nINCLUSION CRITERIA:\n\n1. Women (or men) aged ≥ 18 years with histologically proven breast cancer\n2. Metastatic relapse or locally advanced breast cancer\n3. No-HER2 overexpression or amplification\n4. Triple-negative (defines as ER\\\u003C1%, PR\\\u003C1% and HER2-negative as per ASCO CAP guidelines) or hormone receptor positive (defines as ER and or PR ≥ 1%) breast cancer\n5. Patients with metastases that can be biopsied except bone metastases\n6. ECOG Performance Status ≤ 2\n7. Patients, with deleterious germline BRCA 1 and\u002For 2, in progression under PARPi alone (talazoparib or olaparib)\n8. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol\n9. Patient affiliated to a Social Health Insurance in France\n\nNON-INCLUSION CRITERIA:\n\n1. Abnormal coagulation contraindicating biopsy\n2. Bone metastases when this is the only site of biopsiable disease\n3. Patient pregnant, or breast-feeding\n4. Patients with a known history of Human Immunodeficiency Virus (HIV)\n5. Patients with known active Hepatitis B or C\n6. 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\n7. Patients already participating in the main REPARP study\n8. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)",{"count":332,"type":21},[24],"The purpose of this study is to assess whether expression of not only POLQ\u002FPolθ, but also Shieldin complex and\u002For 53BP1 are correlated with primary and\u002For acquired resistance to PARPi (Poly(ADP-Ribose) Polymerases inhibitors) in a sub-population of locally advanced or metastatic breast cancer patients and vary regarding type and location of gBRCA1\u002F2 mutations.\n\nThis translational research program is composed of two multicentric, non-randomized prospective studies in patients with HER2-negative locally advanced or metastatic breast cancer:\n\n* The main study concerns 80 patients eligible for PARPi (according to the investigators).PARPi treatments (talazoparib or olaparib) will be administered and dosed according to the standard of care administration.\n* The sub-study concerns 40 patients in progression disease under PARPi alone.\n\nFor each included patient in the main study or sub-study, tumor biopsy specimen and blood samples will be collected at different times during the study.",[362],[489,490,491,492,493,494,495,496],"Breast cancer","Germline BRCA mutation","PARP inhibitor","Biomarkers","POLQ","Polθ","Shieldin complex","53BP1","2026-02-18",{"date":499,"type":36},"2026-02-20",{"date":501,"type":36},"2022-06-23",{"date":503,"type":21},"2027-06",{"name":42,"class":43},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":518,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":528,"locationsCount":70},"100533155","study-of-biologic-tumor-and-plasma-biomarkers-of-response-to-ttfields-in-patients-treated-for-newly-diagnosed-glioblastoma-100533155","NCT06222138","Study of Biologic Tumor and Plasma Biomarkers of Response to TTFields in Patients Treated for Newly Diagnosed Glioblastoma","EXOFIELDS","Inclusion Criteria:\n\n1. Age ≥18 years at the time of study entry.\n2. Patient with newly diagnosed glioblastoma.\n3. Patient for which a treatment with radio-chemotherapy followed by TTFields has been decided and has not been started.\n4. Signed written informed consent.\n5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol\n6. Patient affiliated to a Social Health Insurance in France.\n\nExclusion Criteria:\n\n1. Any condition contraindicated with sampling procedures required by the protocol.\n2. Any contraindication to the use of the medical device administering TTFields.\n3. Simultaneous participation in a therapeutic interventional clinical trial.\n4. Patient pregnant, or breast-feeding.\n5. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n6. 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\n7. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)",{"count":513,"type":21},80,[24],"This trial is a translational, open-label, monocentric prospective study of 80 patients aiming to study resistance mechanisms as well as biomarkers of resistance or sensitivity to TTFields.\n\nThe study will be conducted on a population of patients with newly diagnosed glioblastoma treated with radio-chemotherapy followed by TTFields in the context of either routine care or a clinical trial.\n\nIn this study, the Optune® system (battery operated device which delivers TTFields to the brain) will not be under investigation.\n\nFor each included patient, blood samples will be collected during baseline visit (before initiation of radio-chemotherapy), then before initiation of TTFields and every 3 months during TTFields treatment. Additional blood samples will be scheduled at recurrence (if applicable).\n\nMoreover, tumor samples (formalin paraffin embedded (FFPE) tumor block and fresh samples) will be collected from surgery specimen on primary tumor by the sponsor for analysis. In case of recurrence, and if a second surgery is possible, tumor samples will also be collected.\n\nTumor samples will be collected from biopsies taken in the course of routine practice and from surgical specimens collected during surgical procedure. No additional biopsies will be performed for the study.\n\nPatients will be followed-up for time to progression and overall survival for a maximum duration of 24 months from the TTFields initiation.\n\nMRI performed by patients during the course of the study will be collected by the sponsor for additional future research purposes.",[517],"Glioblastoma",[517,519,520,521],"Biologic tumor and plasma biomarkers","Translational research","TTFields","2026-02-11",{"date":524,"type":36},"2026-02-13",{"date":526,"type":36},"2024-08-27",{"date":171,"type":21},{"name":42,"class":43},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":533,"acronym":534,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":22,"phases":538,"briefSummary":539,"conditions":540,"keywords":542,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":70},"100610926","breast-cancer-organelle-properties-and-protein-expression-atlas-in-the-three-immunohistochemical-subtypes-of-breast-cancers-100610926","NCT07233928","Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Cancers","ESPRESSOBREAST","* Inclusion Criteria:\n\n  1. Patient (women or men) with histologically documented breast cancer\n  2. Early Breast Cancer (eBC) or de novo metastatic BC (dnMBC), regardless the immunohistochemical subtype: Triple Negative BC (ER-negative \\[\\\u003C10%\\], PR-negative \\[\\\u003C10%\\] and HER2-negative \\[i.e. null, ultra-low or low\\] BC); HER2-positive BC: HER2 overexpression score 3+ or ERBB2 amplification whatever ER\u002FPR expression and proliferation level; Luminal A-like BC: low to moderately proliferative (Ki67\\\u003C20%) ER-positive (≥ 10%) PR-positive (≥ 20%) BC and low proliferative (Ki67\\\u003C 14%) ER-positive PR-negative (\\\u003C 20%) BC; Luminal B-like BC: highly proliferative (Ki67≥ 20%) ER-positive, PR-positive BC or moderately proliferative (14% ≤ Ki67\\\u003C 20%) ER-positive PR-negative (\\\u003C20%) BC\n  3. Age ≥ 18 years at the time of study entry\n  4. Patient followed within a standard of care procedure or clinical trial\n  5. ECOG performance status ≤ 2\n  6. Breast cancer treatment not yet started\n  7. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol\n  8. Patient affiliated to a Social Health Insurance in France.\n* Exclusion Criteria:\n\n  1. Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or Hanta virus.\n  2. Abnormal coagulation contraindicating biopsy\n  3. Previous or on going treatment for the breast cancer\n  4. Bone metastases when this is the only site of biopsiable disease for dnMBC patients\n  5. Any condition contraindicated with blood sampling procedures required by the protocol (including Hemoglobin \\\u003C 8g\u002Fdl)\n  6. Patients with known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer\n  7. Patient pregnant, or breast-feeding\n  8. 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.\n  9. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship.",{"count":537,"type":21},1050,[24],"This trial is a translational, open-label, monocentric and prospective cohort study of participants with breast cancer aiming to create a combined ESPRESSO (= organelle properties) phenotype and spatial proteomics data collection encompassing four cohorts:\n\n* TN eBC = cohort A,\n* HER2+ eBC = cohort B,\n* Luminal eBC = cohort C,\n* dnMBC = cohort D. In total 1050 participants will be enrolled in the study. Laboratory analysis (including ESPRESSO technique) will be conducted on the biological specimen collected during this study.\n\nThe primary objective is to describe the amount of fatty acids accumulated in lipid droplets, within the four cohorts. As a secondary objective, the analysis will expand to other organelles like lysosomal acidity and nuclear organization.\n\nThe study is due to last 9 years (4 years of recruitment and 5 years of study participation)",[541,243],"Early Breast Cancer",[338,543,544,545,546],"organelle","lipid droplets","protein expression atlas and heterogeneity","metabolism","2026-02-09",{"date":549,"type":36},"2026-02-10",{"date":551,"type":36},"2026-02-06",{"date":553,"type":21},"2035-02-06",{"name":42,"class":43},{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":22,"phases":564,"briefSummary":565,"conditions":566,"keywords":568,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":578},"100558958","phase-2-reduction-in-the-number-of-chemotherapy-cycles-in-combination-with-pembrolizumab-in-first-line-treatment-of-pd-l1-positive-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinomas-100558958","NCT06557889","Reduction in the Number of Chemotherapy Cycles in Combination With Pembrolizumab in First-line Treatment of PD-L1-positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinomas","REDUCE","Inclusion Criteria:\n\n1. Age ≥ 18 years old on the day of signing the informed consent.\n2. Diagnosis of histologically proven recurrent or metastatic squamous cell carcinoma of the head and neck not accessible to treatment with curative intent.\n3. Patients must not have received previous systemic therapy administered in the context of recurrent or metastatic disease.\n4. If the patient received chemotherapy with a platinum salt as part of multimodal treatment for locally advanced disease, it must have ended at least 6 months before signing the consent.\n5. Eligible primary tumor locations are the oropharynx, oral cavity, hypopharynx and larynx. Subjects cannot have a primary tumor site (any histology) in the nasopharynx, sinuses, nasal cavity, salivary glands, or skin.\n6. Documented Combined Positive Score (CPS) PD-L1 ≥ 1 (determined according to local practices in each center) Note: the CPS score can be performed on a new biopsy or on an archived tumor specimen, without date limitation.\n7. Have measurable disease on CT-scan (or on MRI of the neck if it provides a better measurement of the primary tumor according to standard practice and the investigator judgement) according to RECIST 1.1 as determined by the investigator. Tumor lesions located in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. Note : In case of neck MRI assessment, the chest, abdominal, and pelvic CT scan must be performed in addition to assess potential metastases.\n8. Have a performance status of 0 or 1 on the ECOG performance scale.\n9. Demonstrate adequate organ function as defined in the protocol.\n10. Have HPV status test results for oropharyngeal cancers defined as a p16 immunohistochemical (IHC) test (determined according to local practices in each center).\n\n    Note: Cancers of the oral cavity, hypopharynx, and larynx are not required to perform HPV testing by p16 IHC because, by convention, these tumor locations are assumed to be HPV negative.\n11. Female subjects of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study treatment.\n12. Female subjects of childbearing potential must be willing to follow at least one method of contraception or be surgically sterile, or abstain from heterosexual activity for the duration of the study and until 4 months for pembrolizumab, 6 months for carboplatin and 5-fluorouracil, and 7,5 months for cisplatin after the last dose of study treatment respectively for each molecule. Subjects of childbearing potential are those who have not been surgically sterilized and who had menstruation in the last 12 months.\n\n    Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception.\n13. Male subjects must agree to use at least one method of contraception for the duration of the study and until 180 days after the last dose of study treatment.\n\n    Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception.\n14. Signed written informed consent\n15. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol\n16. Patient affiliated to a Social Health Insurance in France\n\nExclusion Criteria:\n\n1. Has a disease accessible to local treatment with curative intent.\n2. Has a progressive disease within six months following the end of primary treatment with curative intent, if this treatment included systemic treatment with platinum salt.\n3. Has a complete DPD enzyme deficiency, suggested by an uracilemia \\> or equal to 150 ng\u002FmL.\n4. Has a contraindication to full dose use of a platinum salt, 5-Fluorouracil, or pembrolizumab, in the opinion of the investigator (dose reductions in cycle 1 are not authorized, except in the case of adaptation of the 5-FU due to partial DPD deficiency); the investigator must refer to the SmPC of the products used in this trial (carboplatin, cisplatin, 5-fluorouracil, and pembrolizumab).\n5. The patient must not have received antibiotics within 14 days before inclusion in the trial.\n6. Received radiotherapy (or other non-systemic therapy) within 2 weeks prior to inclusion.\n7. Subject has not fully recovered (i.e. ≤ Grade 1) from adverse events due to previously administered treatment.\n\n   Note: Subjects with neuropathy ≤ Grade 2, alopecia ≤ Grade 2, or laboratory values not exceeding the limits in Table 1 (See the protocol) are an exception to this criterion and may be eligible for the study Note: If the subject has undergone major surgery, they must have adequately recovered from the toxicity and\u002For complications of the procedure before starting treatment.\n8. Currently participating in and receiving study treatment, or has participated in a study of an investigational agent, or used an investigational device, within 4 weeks prior to the first dose of treatment.\n\n   Note: Participation in the follow-up phase of a previous study is permitted (if the patient is no longer receiving treatment in that study).\n9. Has a life expectancy of less than 3 months and\u002For has a rapidly progressing illness (eg, tumor bleeding, uncontrolled tumor pain) in the opinion of the investigator.\n10. Has a diagnosis of immunodeficiency or is receiving systemic corticosteroid therapy \\> 10 mg\u002Fday of prednisone equivalent or any other form of immunosuppressive therapy within 7 days before the first dose of trial treatment. The use of corticosteroids as premedication for allergic reactions (e.g., IV contrast) or as prophylactic management of adverse events related to protocol-specified chemotherapies is permitted.\n11. Has a diagnosis of a second cancer diagnosed and\u002For treated within 5 years preceding inclusion, with the exception of: curatively resected basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, curatively resected in situ cervical cancer and curatively resected in situ breast cancer.\n\n    Note: The 5 year period does not apply to the cancer for which the subject is enrolled in the trial.\n12. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n\n    Note: Subjects with previously treated brain metastases may participate provided they have been stable (without evidence of progression by imaging using the same imaging modality for each assessment, either MRI or CT) for at least 4 weeks prior to the first dose of trial treatment, and without neurological symptoms, have no signs of new or progressing brain metastases, and are not using steroids \\> 10mg\u002Fday of prednisone equivalent for at least 7 days before study inclusion. This exception does not include carcinomatous meningitis which is excluded regardless of the clinical situation.\n13. Active autoimmune disease that has required systemic treatment within the past 2 years (i.e. with the use of corticosteroids or immunosuppressive drugs). Replacement therapy (for example: thyroxine, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n14. Has undergone solid tissue\u002Forgan allograft or hematopoietic allograft.\n15. Has a history of or has non-infectious pneumonia requiring corticosteroids.\n16. Has an active infection requiring systemic anti-infectious treatment.\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that could interfere with the results of the trial or with the subject's participation throughout the duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the investigator.\n18. Is pregnant or breastfeeding, or expects to conceive or father children during the planned duration of the trial, beginning the screening visit through and until 4 months for pembrolizumab, 6 months for carboplatin and 5-fluorouracil, and 7,5 months for cisplatin after the last dose of study treatment respectively for each molecule.\n19. Has previously received treatment with an anti-PD-1 or anti-PD-L1 agent for the treatment of the cancer for which the patient is included in the trial, whether as part of the primary treatment or as part of the relapse.\n20. Has a known history of human immunodeficiency virus (HIV) infection.\n21. Has known active hepatitis B or C.\n22. Received a live vaccine within 30 days before the planned start of study treatment.\n23. Has a known history of hypersensitivity to fluorouracil, carboplatin, cisplatin or pembrolizumab or to any of their excipients, according to the SmPCs of these products.\n24. For patient receiving the treatment with 5-fluorouracil: has clinically significant active heart disease or myocardial infarction within 6 months; has received a recent or has a concomitant treatment with brivudine (4 weeks before or after 5-FU).\n25. For patient receiving the treatment with cisplatin: has a neuropathy caused by cisplatin, has a hearing problem, has a treatment with phenytoin with prophylactic aim.\n26. For patient receiving the treatment with pembrolizumab: has a history of uncontrolled or symptomatic cardiac disease.\n27. 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\n28. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)",{"count":563,"type":21},86,[213],"This is a phase II, prospective, non-randomized, single-arm, multicentric study to evaluate the activity and safety of treatment with 4 cycles (instead of 6) of chemotherapy (platinum (cisplatin or carboplatin) and 5-Fluorouracil) in combination with pembrolizumab for the first-line treatment of CPS PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma.\n\nA total of 86 patients will have to be enrolled in this study.",[567],"Squamous Cell Carcinoma of Head and Neck",[567,569,279,570,571],"Pembrolizumab","Carboplatin","5-fluorouracil",{"date":522,"type":36},{"date":574,"type":36},"2024-10-21",{"date":576,"type":21},"2030-09",{"name":42,"class":43},14,{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":600,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":605,"locationsCount":606},"100360033","multimodal-immune-characterization-of-rare-soft-tissue-sarcoma---miras-project-from-sarra-sarcome-rare-project-of-the-french-sarcoma-group-100360033","NCT03967834","Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group","MIRAS","Inclusion Criteria:\n\n1. Age ≥18 years at the time of study entry.\n2. Diagnosis of one of the following rare sarcoma subtype, confirmed by RRePS network:\n\n   * Clear Cell Sarcoma (CCS)\n   * Epithelioid Sarcoma (ES)\n   * Perivascular Epithelioid Cell neoplasm (PEComa)\n   * Desmoplastic Small Round Cell Tumours (DSRCT)\n   * Malignant Solitary Fibrous Tumours (mSFT)\n   * Alveolar Soft Part Sarcoma (ASPS)\n   * Epithelioid Hemangioendothelioma (EH)\n   * Low-Grade Fibromyxoid Sarcoma (LGFS)\n   * Sclerosing Epithelioid Fibrosarcoma (SEF).\n3. Localized\u002Flocally advanced or metastatic disease.\n4. In case of localized disease, treatment must not have been yet initiated before inclusion (except surgical excision).\n5. In case of metastatic disease, project of new line of systemic treatment must have been decided before inclusion.\n6. Patient followed in the center within a standard of care procedure or clinical trial.\n7. Archived tumor specimen at initial diagnosis available (before treatment initiation).\n8. Evaluable disease (measurable as per RECIST 1.1) or not.\n9. ECOG Performance status 0-3.\n10. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.\n11. Patient affiliated to a Social Health Insurance in France.\n\nExclusion Criteria:\n\n1. Diagnosis of all other histotypes of soft tissue sarcoma.\n2. Any condition contraindicated with procedures required by the protocol.\n3. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n4. 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.\n5. Pregnant or breast-feeding woman.\n6. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under guardianship.",{"count":587,"type":21},400,[24],"This trial is a translational, open-label, multi-sites, prospective and retrospective cohort study of 500 patients aimed at clinical and biological characterization of sarcoma of rare subtype.\n\n400 patients will be included in this prospective cohort study; they will be identified in the investigating centers in the context of either routine care or a clinical study protocol.\n\nRetrospective cases of patients (100 cases in total) will be identified in all centers through the GSF\u002FGETO clinical databases already setted up (including the clinical base Conticabase).",[216,591,592,593,594,595,596,597,598,599],"Clear Cell Sarcoma","Epithelioid Sarcoma","Perivascular Epithelioid Cell Neoplasms","Desmoplastic Small Round Cell Tumor","Malignant Solitary Fibrous Tumors","Alveolar Soft Part Sarcoma","Epithelioid Hemangioendothelioma","Low Grade Fibromyxoid Sarcoma","Sclerosing Epithelioid Fibrosarcoma",[216,591,592,593,594,595,596,597,598,599],{"date":549,"type":36},{"date":603,"type":36},"2021-04-26",{"date":40,"type":21},{"name":42,"class":43},20,{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":52,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":22,"phases":616,"briefSummary":617,"conditions":618,"keywords":620,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":632},"100514860","study-for-characterisation-of-predictive-parameters-of-clonal-evolution-in-subjects-with-gata2-germline-mutation-100514860","NCT05983991","Study for Characterisation of Predictive Parameters of Clonal Evolution in Subjects With GATA2 Germline Mutation","GATA-2 Project: Retrospective and Prospective Exploratory Study for Characterisation of Predictive Parameters of Clonal Evolution in Subjects With GATA2 Germline Mutation","GATA-2","Inclusion Criteria:\n\n1. All subject, at any age, with a germline GATA2 mutation.\n2. Patient followed in the center within a standard of care procedure or clinical trial.\n3. Signed written informed consent. For minor patients: patient assent and legal guardian(s) written informed consent obtained before inclusion in the study and prior performance of any study-related procedure.\n4. For French patients: patient affiliated to a Social Health Insurance.\n\nExclusion Criteria:\n\n1. GATA2 somatic mutation.\n2. 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.\n3. Person who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection, with the exception of persons under curatorship who may be included in the study.",{"count":20,"type":21},[24],"This trial is a translational, open-label, multi-site, retrospective and prospective cohort study of 250 patients aiming to characterize predictive parameters of clonal evolution in a population of subjects carrying the germline GATA2 mutation.\n\nThis study will be conducted on a population of subjects either with previous germline GATA2 mutation identified or newly identified for germline GATA2 mutation in the context of routine care.\n\nProspective cohort:\n\n150 subjects will be included in this interventional prospective cohort study:\n\n* Alive subjects previously identified with a germline GATA2 mutation through the already existing \"Neutropenia database\";\n* Subject identified in the investigating centers in the context of a newly identified germline GATA2 mutation.\n\nFor each included patient, biological samples (blood and bone marrow samples) will be collected at baseline visit and then during 5 years, according to the samples taken in the standard practice. No additional sampling will be performed for the study.\n\nRetrospective cohort:\n\nSubjects (100 cases in total) previously identified with germline GATA2 mutation through the already existing \"Neutropenia database\" and with the following features may enter the retrospective cohort:\n\n* Deceased patients,\n* Lost to follow-up patients. Clinical follow-up data will be obtained from this database and\u002For patient's medical report.\n\nFor each retrospective case, archived blood and bone marrow samples (collected in a sanitary setting) will be sent to sponsor's centralized unit for analysis.",[619],"GATA2 Gene Mutation",[619,621,622,623],"Myelodysplastic Syndromes","Acute myeloid Leukemia","Spectrum 2","2025-12-19",{"date":626,"type":36},"2025-12-26",{"date":628,"type":36},"2023-12-07",{"date":630,"type":21},"2033-12",{"name":42,"class":43},23,{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":52,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":22,"phases":642,"briefSummary":643,"conditions":644,"keywords":646,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":660},"100517782","study-of-families-with-an-hemopathies-predisposition-related-to-the-ddx41-gene-100517782","NCT06022016","Study of Families With an Hemopathies Predisposition Related to the DDX41 Gene.","LUCID","Index cases:\n\nInclusion Criteria:\n\n1. Women or man aged ≥ 18 years old.\n2. Personal history(s) of hemopathy or patient with hemopathy at the time of inclusion.\n3. Patient with a tumor mutation of DDX41 with an allelic frequency (AF) ≥ 30% (with total depth of nucleotide position \\>300x: provide tumor molecular analysis report).\n\n   Special case of inclusion of deceased index cases: the DDX41 tumor mutation of interest must be accompanied by another somatic DDX41 mutation (the most frequent being p.R525H).\n\n   Or patient known to be a constitutional carrier of a DDX41 mutation confirmed after oncogenetic consultation (in this case, provide constitutional analysis report).\n4. Patient (or beneficiary) agreeing to release results of oncogenetic report.\n5. Patient (or beneficiary) agrees to communicate the contact details of his relatives and that they may be contacted by mail to participate in the LUCID study.\n6. Patient affiliated to a Social Health Insurance in France.\n7. Patient able to participate and willing to give informed consent prior performance of any study-related procedures.\n\nExclusion Criteria:\n\n1. No history of hemopathy or no current hemopathy.\n2. Patient (or beneficiary) unable to complete questionnaire for social or psychological reasons.\n3. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).\n\nRelated cases (Family member):\n\nInclusion Criteria:\n\n1. Women or man aged ≥ 18 years old.\n2. Related to an index case included in the LUCID study.\n3. Agreeing to carry out a scientific salivary test for the constitutional research of the DDX41 mutation.\n4. Patient affiliated to a Social Health Insurance in France.\n5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures.\n\nExclusion Criteria:\n\n1. Not applicable from version 2 of the protocol. Related in the 4th or 5th degree to an index case included in the LUCID study.\n2. Person already identified as an index case in the LUCID study.\n3. Person unable to complete questionnaire for social or psychological reasons.\n4. Person who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).",{"count":641,"type":21},910,[24],"This is a multicenter, interventional, historico-prospective cohort pilot study aimed at specifying the phenotype of subjects carrying a constitutional familial DDX41 mutation, with a view to eventually publishing oncogenetic recommendations for carriers of this mutation.\n\nThe main objective of the LUCID project is to assess the cumulative risk of hematological diseases as a function of age in DDX41 germline mutation carriers.\n\nThis study will be carried out in two stages:\n\nStage 1: Inclusion of index cases in an oncogenetic consultation (salivary test, completion of an health self-questionnaire and collection of contact details for the related cases).\n\nStage 2: Proposition of participation to family members, by correspondence, and determination of carrier or non-carrier status of the constitutional familial DDX41 mutation (based on a salivary test).\n\nA maximum of 210 index case patients and 700 family member will be included in this study.",[645],"DDX41 Gene Mutation",[647,648,649,650,651],"GermlIne DDX41 mutation","Myelodysplastic Syndrome","Acute Myeloid Leukemia","Idiopathic Cytopenia","LeUkemia","2025-12-01",{"date":654,"type":36},"2025-12-08",{"date":656,"type":36},"2023-11-17",{"date":658,"type":21},"2030-01",{"name":42,"class":43},5,{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":665,"acronym":666,"eligibilityCriteria":667,"healthyVolunteers":12,"sex":329,"minAge":18,"maxAge":4,"enrollmentInfo":668,"targetDuration":4,"studyType":22,"phases":669,"briefSummary":670,"conditions":671,"keywords":673,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":677,"lastUpdatePostDateStruct":678,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":70},"100586623","prostate-cancer-burden-and-heterogeneity-evaluation-towards-liquid-biopsy-a-correlation-study-to-18fdcfpyl-pet-and-patients-outcome-100586623","NCT06917781","Prostate Cancer Burden and Heterogeneity Evaluation Towards Liquid Biopsy: a Correlation Study to 18FDCFPyL PET and Patients Outcome","TAYLOR","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Histologically confirmed adenocarcinoma of the prostate\n3. Indication for 18F-PET-PSMA imaging\n4. Signed written informed consent\n5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol\n6. Patient affiliated to a Social Health Insurance in France.\n\nExclusion Criteria:\n\n1. Patients with a contraindication to 18F-PET-PSMA\n2. Patient with an established neuro endocrine prostate cancer\n3. Concurrent malignancy known to express a significant amount of PSMA (renal cancer, salivary gland tumors)\n4. 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\n5. Patient who has forfeited his freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).",{"count":513,"type":21},[24],"This is a prospective, monocentric, proof of concept study aims to identify in prostate cancer patients, a potential relationship between CTC-PSMA positivity and 18F-PET-PSMA results as well as patient outcome.\n\nPatients with 18F-PET-PSMA indication will perform imaging extension work-up as part of current practice. If they agree to participate in the study, a blood sample will be performed prior to the 18F-PET-PSMA standard imaging (T1).\n\nIn order to evaluate the potential relationship between CTC-PSMA and 18F-PET-PSMA imaging, the study will be presented to all patients seen in consultation for an extension workup for prostate cancer. This will allow to analyze the results in patients with different level of tumor burden afterward to define the following three groups based on imaging results:\n\nGroup 1 : no tumor volume Negative 18F-PET-PSMA (patients without uptake lesion)\n\nGroup 2 : low or medium tumor volume Positive 18F-PET-PSMA (patients with an uptake in prostate bed or with an oligo-metastatic extension (number of lesions \\\u003C 6))\n\nGroup 3 : high tumor volume Positive 18F-PET-PSMA (patients with a polymetastastatic extension (number of lesions ≥ 6)).\n\nIn each of these groups, the rate of patients with positive PSMA CTC will be analyzed (i.e. patient having at least one CTC-PSMA positive).\n\nFor patients with an indication of treatment by 177LuPSMA-617 (PLUVICTO®) according to standard practices, additional blood samples will also be collected at the following time points: 2nd cycle (T2) and 4th cycle of treatment (T3), just before injection. For these patients, data will be collected up to 6 months after the last treatment injection (clinical and biological data; results of tumor assessments based on 18F-PET-PSMA imaging).",[672],"Prostate Cancer",[672,674,675,676],"18F-PET-PSMA","Circulating Tumor Cells","Liquid biopsy","2025-11-14",{"date":679,"type":36},"2025-11-18",{"date":681,"type":36},"2025-10-28",{"date":683,"type":21},"2028-10",{"name":42,"class":43},""]