[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":445},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,51,78,105,136,164,189,214,243,267,295,319,345,374,399,422],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100570945","phase-3-impact-aml-a-randomized-pragmatic-clinical-trial-for-relapsed-or-refractory-acute-myeloid-leukemia-100570945",false,"NCT06713837","IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.","IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. IMPACT-AML RPCT","IMPACT-AML","Inclusion Criteria:\n\n* Non-Acute promyelocytic leukemia (APL) AML defined according World Health Organization (WHO) 2022 (or International Consensus Classification (ICC) 2022) criteria\n* 1st or 2nd relapse or refractory according to European leukemia Network (ELN) 2022\n* Patient is clinically candidate to both low intensity therapy and high dose chemotherapy in the opinion of the physician\n* Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice\n* No specific treatment protocol can be rationally considered better suited to patient needs.This specifically include, but is not limited to:\n\n  i) the availability of a drug that is already demonstrated superior to comparator arm and can be considered the only standard of care ii) specific contraindications related to fitness or any medical conditions that deem to avoid one of the two arms of this randomization iii) patient willingness to avoid one of the two arm of this randomization iv) lack of social support that make unfeasible one of the two arm of this randomization\n* Male or Female, aged\\>18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C4\n* A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be obtained. WOCBP must adopt highly effective birth control methods, according to guideline \"Recommendation related to contraception and pregnancy testing in clinical trials\". Male patient and his female partner who is of childbearing potential must use 2 methods of birth control (a condom as a barrier method of contraception and one of the highly effective birth control methods, according to guideline \"Recommendation related to contraception and pregnancy testing in clinical trials\". Use of- and compliance to- birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug.\n* Participant is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment, according to most update version of Summary of Product Characteristics (SmPC) (e.g. hypersensitivity, allergy, organ failure precluding treatment)\n* Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization\n* Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.","ALL","18 Years",{"count":20,"type":21},339,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)",[27,28],"Acute Myeloid Leukemia","Relapse\u002FRecurrence",[30,27,31,32,33,34,35,36,37],"Relapsed\u002FRefractory","Low Intensity therapy","Pragmatic","Low intervention Clinical trial","Randomized controlled trial","Horizon Europe","Mission Cancer","Diagnosis and treatment","RECRUITING","2026-06-09",{"date":41,"type":42},"2026-06-10","ACTUAL",{"date":44,"type":42},"2025-02-27",{"date":46,"type":21},"2028-01",{"name":48,"class":49},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","OTHER",47,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100551356","master-framework-for-relapse-or-refractory-acute-myeloid-leukemia-100551356","NCT06459024","Master Framework For Relapse or Refractory Acute Myeloid Leukemia","Master Framework For Relapse or Refractory Acute Myeloid Leukemia- IMPACT STREAM - A Prospective Observational Study of Treatment Outcomes","IMPACT STREAM","Inclusion Criteria:\n\n* Patients with AML diagnosis according to WHO2022 or ICC2022\n* Treatment failure (i.e. relapse, refractory or progression, including MRD) according to ELN2022 criteria\n* Participant or his\u002Fher legal representative is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Patients included in clinical trials may be enrolled except where otherwise specified in the experimental protocol.","6 Years",{"count":61,"type":21},4000,"OBSERVATIONAL","This is an observational (non-interventional), prospective, cohort study that will collects data from patients diagnosed with relapsed or refractory acute myeloid leukemia afferent to the participanting clinical sites",[65,66],"Acute Myeloid Leukemia, in Relapse","Acute Myeloid Leukemia Refractory",[68,69,27,70],"Relapsed","Refractory","Framework",{"date":41,"type":42},{"date":73,"type":42},"2024-06-28",{"date":75,"type":21},"2032-07",{"name":48,"class":49},38,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":86,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100507898","phase-2-lu-psma-and-stereotactic-radiotherapy-versus-radiotherapy-alone-for-prostate-cancer-lust-100507898","NCT05893381","Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Prostate Cancer (LUST)","A Phase II Randomized Trial of Lu-PSMA and Stereotactic Radiotherapy Versus Radiotherapy Alone for Oligometastatic Prostate Cancer (LUST)","LUST","Inclusion Criteria:\n\n1. Patients with prostate cancer must have 1-3 asymptomatic metastatic lesions that are ≤ 5.0 cm or \\\u003C 250 cm3 documented at CT\u002FMRI or WBD-MRI.\n2. PSMA-PET\u002FCT positive scan matching with lesions documented on baseline CT\u002FMRI or WBD-MRI.\n3. Patients must have had their primary tumor treated with surgery and\u002For radiation and previous salvage radiation to the prostate bed or pelvis is allowed.\n4. Patients will be admitted to the therapeutic phase only if diagnostic PET\u002FCT PSMA SUV max is ≥ 3.\n5. Histologic confirmation of malignancy (primary or metastatic tumor).\n6. Prostate specific antigen (PSA) ≥ 0.2 ng\u002FmL but ≤ 50 ng\u002FmL and Testosterone ≥ 125 ng\u002FdL.\n7. PSA doubling time (PSADT) \\\u003C 15 months. PSADT will be calculated using as many PSA values that are available from time of relapse (PSA \\> 0.2 ng\u002FdL).\n8. Patients unfit or refusing ADT.\n9. Patients may have had prior systemic therapy and\u002For ADT associated with treatment of their primary prostate cancer. Patients may have had ADT associated with salvage radiation therapy.\n10. Patients must be ≥ 18 years of age.\n11. Patient understands the purpose of the study and the procedures required for it; the patient is willing to participate in the study and to sign a written informed consent document.\n12. Patients must have an Eastern Cooperative Oncology Group performance status ≤ 2.\n13. Patients should have a life expectancy of at least 6 months.\n14. Patients must have normal organ and marrow function as defined as:\n\n    * Leukocytes \\>2,000\u002FμL;\n    * Absolute neutrophil count \\>1,000\u002FμL;\n    * Platelets \\>75,000\u002FμL;\n    * total bilirubin within normal institutional limits (this will not apply to patients with confirmed Gilbert's syndrome);\n    * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 X institutional upper limit of normal;\n    * Creatinine within normal institutional limits.\n15. If the participant engages in sexual activity with a woman of childbearing potential, a condom must be used together with another highly effective method of contraception during the Treatment Period and for 6 months after the last dose of study intervention. The participant must agree not to donate sperm for the purpose of reproduction during the Treatment Phase and for a minimum of 6 months after receiving the last dose of study intervention.\n16. Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. Patients and female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception, see Appendix F) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required ( established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg., bilateral orchiectomy), for more than 6 months.\n\n16\\. Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. Patients and female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception, starting at screening and continuing throughout the study period and for 6 months after final study drug administration.\n\nExclusion Criteria:\n\nThe participant may not enter the study if ANY of the following apply:\n\n1. No more than 3 years of ADT is allowed, with the most recent ADT treatment having occurred more than 6 months prior to enrollment.\n2. PSMA -PET\u002FCT scan more than 3 months.\n3. Spinal cord compression or impending spinal cord compression.\n4. Suspected pulmonary and\u002For liver metastases.\n5. Bone metastasis in a femoral bone.\n6. Previous radiation therapy on the metastatic site.\n7. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. A window of 3 days is permitted.\n8. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. A window of 3 days is permitted.\n9. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant.\n10. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n11. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177-Lu-PSMA- I \\& T or other agents used in the study.\n12. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n13. Unable to lie flat during or tolerable SABR.\n14. Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 3 years (except for previously treated basal cell carcinoma);\n15. Known HIV-positivity, whether or not symptomatic.","MALE",{"count":88,"type":21},70,[90],"PHASE2","Multicenter, open-label, parallel-group, phase II randomized study in patients with oligometastatic prostate cancer with 1-3 asymptomatic metastases of the soft tissue or bone. Eligible patients will be randomized at 1:1 ratio to Stereotactic Radiotherapy followed by Lu-PSMA (arm A) or Stereotactic Radiotherapy (arm B)",[93],"Prostate Cancer",[95],"PSMA PET\u002FCT positive","2025-12-02",{"date":98,"type":42},"2025-12-03",{"date":100,"type":42},"2023-06-27",{"date":102,"type":21},"2032-04",{"name":48,"class":49},2,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},"100402701","phase-2-vaccination-with-autologous-dendritic-cells-loaded-with-autologous-tumour-homogenate-in-glioblastoma-100402701","NCT04523688","Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma","Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma: a Phase II Study","Combi G-Vax","After signing the informed consent form for pre-screening, patient will assess the procedures to obtain sufficient leukapheretic material for the dendritic cell vaccine manufacturing and will perform the standard radiochemotherapy treatment (Stupp regimen) for the disease.\n\nFor the pre-screening phase of the study the eligibility criteria are:\n\n1. Histologically confirmed \"monofocal\" glioblastoma\n2. Near-complete resection (= 5 ml residual tumor volume) confirmed by \"central neuroradiologist on magnetic resonance imaging (MRI) or CT scan within 72 h postoperative\"\n3. Karnofsky performance status (KPS) = 70% or performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Appendix A)\n4. Be willing and able to provide written informed consent\u002Fassent for the pre-screening phase of the trial.\n5. Be = 18 years of age on day of signing informed consent.\n6. Life expectancy of greater than 12 weeks.\n7. Patient suitable for the collection of biological material from leukapheresis:\n\n   serological tests HIV, hepatitis B virus (HBV), HCV, Treponema pallidum negative; normal cardiological parameters (ECG and cardiological examination); evaluation by transfusionist to exclude possible contraindications to leukapheresis.\n8. Patient candidate to standard radiochemotherapy (Stupp regimen)\n9. Appropriate 12-lead ECG and echocardiogram.\n\nAfter pre-screening, patient will be enrolled based on subsequent Inclusion Criteria:\n\n1. Histologically confirmed \"monofocal\" glioblastoma\n2. THE AUTOLOGOUS SURGICAL SPECIMEN NEEDED FOR VACCINE MANUFACTURING MUST HAVE BEEN COLLECTED AND SENT TO THE SOMATIC CELL THERAPY LAB OF ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) ISTITUTO DI RICOVERO E CURA A CARATTERE SCIENTIFICO (IRCCS) AND MUST FULFIL ALL THE ACCEPTANCE CRITERIA PRESCRIBED BY THE GOOD MANUFACTURING PRACTICES (GMP) PROCEDURES.\n3. Availability of sufficient leukapheretic material for the preparation of the vaccine product.\n4. No progressive disease near-complete resection (= 5 ml residual tumor volume) confirmed by MRI after standard radiochemotherapy treatment (Stupp regimen)\n5. Patients must have recovered (grade 1 or less by CTCAE 5.0) from all the events related to previous treatments.\n6. Be willing and able to provide written informed consent\u002Fassent for the trial.\n7. Be \\>= 18 years of age on day of signing informed consent.\n8. Have a Karnofsky performance status (KPS) = 70% or a performance status of 0 or 1 on the ECOG Performance Scale.\n9. Demonstrate adequate organ and marrow function\n\nExclusion Criteria:\n\n1. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy \\> 10 mg prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n2. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n3. Has a known history of active Bacillus Tuberculosis (TB)\n4. Previous treatment with a cancer vaccine\n5. Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years, except basal or squamous cell carcinoma of the skin and in situ carcinoma of the cervix uteri treated with radical surgery.\n6. Any known history of or is positivity of any serologic marker indicative of infection by Treponema pallidum, hepatitis B virus (HBsAg, HBsAb, HBcAB), hepatitis C virus (HCVAb, HCV RNA quantitative), human immunodeficiency virus (HIV), whether actual or previous.\n7. Has received a live vaccine within 30 days of planned start of study therapy.",{"count":114,"type":21},28,[90],"Single arm, monocentric trial to assess the safety and the progression-free survival related to the combined treatment of dendritic cell vaccine loaded with autologous tumor homogenate and temozolomide in patients operated for glioblastoma and then treated with standard radiochemotherapy (according to Stupp regimen).",[118,119],"Glioblastoma","Vaccination",[121,122,123,124,125,126],"glioblastoma","dendritic cells","vaccine","temozolomide","Stupp regimen","cellular therapy","2025-07-17",{"date":129,"type":42},"2025-07-22",{"date":131,"type":42},"2021-03-25",{"date":133,"type":21},"2025-12",{"name":48,"class":49},1,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100487149","phase-2-pembrolizumab-and-olaparib-treatment-of-extensive-small-cell-lung-cancer-es-sclc-100487149","NCT05623319","Pembrolizumab and Olaparib Treatment of Extensive Small Cell Lung Cancer (ES-SCLC)","Phase 2 Trial of Translational Approach to First Line cHemoimmunotherapy Followed by Maintenance With pembrOlizumab and Olaparib in Extensive-Stage Small-Cell Lung CanceR.","THOR","The Inclusion Criteria:\n\n1. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n2. Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent.\n3. Cytologically\u002Fhistologically confirmed diagnosis of SCLC per the Veterans Administration Lung Study Group (VALG) staging system will be enrolled in this study. Patients must have extensive stage (ES) SCLC defined as Stage IV (T any, N any, M 1a\u002Fb\u002Fc) by the American Joint Committee on Cancer, Eighth Edition.\n4. Possibility of obtaining tissue sample, via a biopsy of the primary tumour or metastatic tumour tissue, within the 6 weeks prior to study entry. An archival biopsy is acceptable as long as there has been no intervening anticancer treatment since the time the biopsy was obtained to enrolment in this clinical study and as long as it was within 6 weeks of study entry. Tissue sample would consist of formalin-fixed, paraffin-embedded tumour tissue blocks, or, from formalin-fixed paraffin-embedded tumor tissue block, at least five re-cut, unstained sections of 5 μM thickness for immunohistochemical analysis and five unstained sections of 10 μM thickness for NGS, presented on slides or cell-block.\n5. No prior systemic treatment for ES-SCLC. Patients who have received prior chemo-radiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment free interval of at least 6 months since the last chemotherapy, radiotherapy, or chemoradiotherapy cycle from diagnosis of ES-SCLC.\n6. Patients with thoracic radiotherapy clinically indicated (e.g. mediastinal syndrome) could be enrolled providing they receive radiotherapy not before 15 days since the start of the experimental treatment. Patients who received radiation therapy to the lung fields that is \\> 30 Gy within 6 months of the first dose of trial treatment, will be excluded.\n7. Presence of target lesions by RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of registration .\n9. Patients with paraneoplastic syndromes can be enrolled if an autoimmune origin can be excluded. Autoimmune origin will be defined according to local practice.\n10. Life expectancy ≥12 weeks.\n11. Capacity to swallow.\n12. Ability to comply with the study protocol, in the investigator's judgment.\n13. Have adequate organ function. Specimens must be collected within 10 days prior to the registration day.\n14. Negative human immunodeficiency virus (HIV) test at screening.\n15. Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.\n16. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.\n17. Male participants: Male patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception.\n18. Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n    1. Not a woman of childbearing potential (WOCBP) as defined in Appendix F, or\n    2. A WOCBP who agrees to follow the contraceptive guidance in Appendix F during the treatment period and for at least 120 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n2. Active or history of autoimmune disease or immune deficiency which has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs), including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n   * Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study.\n   * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n   * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n     * Rash must cover less than 10% of body surface area;\n     * Disease is well controlled at baseline and requires only low-potency topical corticosteroids;\n     * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months;\n     * Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n3. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n4. Prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n5. Live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n6. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT interval by Fredericia (QTcF) prolongation \\>500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome. In case of significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident), acute events must happen not before than 3 months prior to initiation of study treatment.\n7. Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study.\n8. History of malignancy other than SCLC within 3 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\>90%), such as, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, Stage I uterine cancer or non-muscle-invasive urothelial carcinoma (Ta - Tis - T1).\n9. History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n10. Active infection requiring systemic therapy.\n11. Known history of active Bacillus Tuberculosis (TB).\n12. Treatment with investigational therapy within 28 days prior to initiation of study treatment.\n13. Patient who has received prior therapy with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, anti-Cytotoxic T-Lymphocyte Associated Protein 4 (CTLA-4), anti-OX40, anti-Cluster of Differentiation 137 (CD137), anti-CD27).\n14. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin-2 (IL-2)) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment.\n15. Any previous treatment with a PARP inhibitor, including Olaparib.\n16. Concomitant use of known strong Cytochrome P450, family 3, subfamily A (CYP3A) inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks.\n17. Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for phenobarbital and 3 weeks for other agents.\n18. Has severe hypersensitivity (≥Grade 3) to pembrolizumab, olaparib and\u002For any of their excipients.\n19. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n20. Known allergy or hypersensitivity to carboplatin or etoposide.\n21. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n22. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n23. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n24. Has had an allogenic tissue\u002Fsolid organ transplant.\n25. A WOCBP who has a positive urine pregnancy test within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.",{"count":145,"type":21},60,[90],"This is an open-label, single arm, phase 2 trial enrolling patients with untreated Extensive-Stage Small-Cell Lung Cancer (ES SCLC), with a strong translational attitude.",[149],"SCLC,Extensive Stage",[149,151,152,153,154],"Translational","Liquid Biopsy","Pembrolizumab","Olaparib","2025-06-18",{"date":157,"type":42},"2025-06-24",{"date":159,"type":42},"2023-03-27",{"date":161,"type":21},"2027-07",{"name":48,"class":49},12,{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"100586747","triple-negative-adult-b-cell-acute-lymphoblastic-leukemia---trineg-all-100586747","NCT06919393","\"Triple Negative\" Adult B-cell Acute Lymphoblastic Leukemia - TRINEG-ALL","\"Triple Negative\" Adult B-cell Acute Lymphoblastic Leukemia: Molecular Characterization, Identification and New Stratification","TRINEG-ALL","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study;\n* Patients with new diagnosis and\u002For relapse\u002Fs of primary or secondary B-ALL;\n* Negative for BCR-ABL1 t(9;22); TCF3-PBX1 t(1;19); MLL-AF4 t(4;11) rearrangements;\n* Participant is willing and able to give informed consent for participation in the study;\n* Male or Female, aged \\>18 years;\n* Availability of clinical data.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years;\n* B-ALL positive for BCR-ABL1 t(9;22); TCF3-PBX1 t(1;19); MLL-AF4 t(4;11) rearrangements.\n\nLow blast percentage (\\\u003C70%) samples could be excluded for molecular evaluations, not for cytofluorimetric analyses;",{"count":145,"type":21},"It is a multicenter, non-interventional, non pharmacological, translational, prospective study. Any decision about drug administration is made by the physician based on his clinical judgment in the context of clinical practice, independently from the decision to include the patient in the study.",[175],"Leukemia, Lymphoblastic",[177,178,179],"lymphoblastic acute leukemia (LAL)","triple negative","B cell","2025-04-07",{"date":182,"type":42},"2025-04-09",{"date":184,"type":42},"2019-10-23",{"date":186,"type":21},"2026-01",{"name":48,"class":49},3,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},"100385545","mixed-molecular-clinical-index-mmci-in-diffuse-large-b-cell-lymphoma-dlbcl-100385545","NCT04300101","Mixed Molecular Clinical Index (MMCI) in Diffuse Large B-cell Lymphoma (DLBCL)","MMCI","Inclusion Criteria for the prospective cohort:\n\n* New diagnosis of High grade Diffuse large B cell Lymphoma undergoing first line standard treatment;\n* Signed written informed consent;\n* Availability of FFPE sample.\n\nInclusion Criteria for the retrospective cohort:\n\n* Diagnosis of High grade Diffuse large B cell Lymphoma from 2011 to 2017;\n* Availability of FFPE sample and clinical data.\n\nExclusion Criteria:\n\n* Patients included in clinical trials.",{"count":197,"type":21},300,"This is a prospective and retrospective observational study. The primary objective is to identify new prognostic biomarkers for DLBCL patients in terms of progression-free survival (PFS) and able to add predictive capacity to recognized important clinical factors.\n\nThe secondary objectives are:\n\n* to identify new biomarkers associated with overall survival (OS) and objective response rate (ORR)\n* to characterize tissue and circulating immune microenvironment of DLBCL patients by bulk and single cell transcriptomics;\n* to assess the correlation between the expression of immune checkpoint genes and mRNA signature;\n* to describe the mutational status of a panel of genes relevant to DLBCL pathogenesis;.\n* to assess the correlation between protein expression, mutational status and the messenger RNA (mRNA) signature.\n* to investigate the association between radiomic features obtained from PET images and patient and tumour characteristics and clinical outcomes (PFS, OS, ORR).\n\nFor each enrolled patient, immunohistochemical determinations will be performed: Cell of origin (COO) (Germinal Cell -GC- or activated B-cell - ABC- type according with Hans algorithm ), evaluation of cluster of differentiation antigen 20 (CD20), cluster of differentiation antigen 5 (CD5), cluster of differentiation antigen 10 (CD10), Bcl6, Bcl2 (cut off\\>50%), Multiple Myeloma 1 \u002F Interferon Regulatory Factor 4 protein (MUM1\u002FIRF4), c-myc (cut off\\>40%) and Ki67, fluorescence in situ hybridization (FISH) for c-myc and if rearranged, for Bcl2 e Bcl6 ). Moreover, paraffin embedded (FFPE) tumor specimens will be collected for RNA extraction and mRNA expression mutational and proteomics analysis, centralized at IRST-IRCCS.",[200],"Diffuse Large B Cell Lymphoma",[202,203,204,205],"Diffuse Large B cell lymphoma;","cell of origin","gene expression","immunohistochemistry",{"date":207,"type":42},"2025-04-10",{"date":209,"type":42},"2020-05-14",{"date":211,"type":21},"2028-05",{"name":48,"class":49},4,{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":223,"conditions":224,"keywords":231,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":188},"100584894","whole-body-mri-in-oncology-100584894","NCT06895291","Whole Body MRI in Oncology","ONCO-MRI","Inclusion Criteria:\n\n* Patients candidate to WB-MRI according to clinical practice belonging to the study groups listed above.\n* Participant is willing and able to give informed consent for participation in the study.\n* Male or Female, aged ≥ 18 years.\n* Life expectancy greater than 3 months.\n\nExclusion Criteria:\n\n* Patients with MRI-unsafe prostheses and devices.\n* Patients whose tests are of suboptimal quality, or whose test has been suspended, or is incomplete.",{"count":222,"type":21},1000,"Multicenter, observational, prospective, study. All patients will be treated and monitored according to the local clinical practice. No additional procedures\u002Fpatient visits in comparison with the usual clinical practice are planned for the study.",[225,226,227,228,229,230],"Lymphoma","Advanced Prostate Cancer","Advanced Breast Cancer","Monoclonal Gammopathy of Undetermined Significance","Smoldering Multiple Myeloma","Multiple Myeloma",[228,232,233,227,226,225,234],"Smoldering multiple myeloma","Multiple myeloma","Whole Body-Magnetic Resonance Imaging","2025-03-25",{"date":237,"type":42},"2025-03-30",{"date":239,"type":42},"2023-10-26",{"date":241,"type":21},"2031-10",{"name":48,"class":49},{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":104},"100556270","phase-2-sequential-immunochemotherapy-treatment-with-pembrolizumab-plus-dendritic-cell-dc-vaccine-followed-by-trifluridinetipiracil-plus-bevacizumab-in-refractory-mismatch-repair-proficient-pmmr-or-microsatellite-stable-mss-metastatic-colorectal-cancer-100556270","NCT06522919","Sequential Immunochemotherapy Treatment with Pembrolizumab Plus Dendritic Cell (DC) Vaccine Followed by Trifluridine\u002FTipiracil Plus Bevacizumab in Refractory Mismatch-repair-proficient (pMMR) or Microsatellite-stable (MSS) Metastatic Colorectal Cancer","Sequential Immunochemotherapy Treatment with Pembrolizumab Plus Dendritic Cell (DC) Vaccine Followed by Trifluridine\u002FTipiracil (FTD\u002FTPI) Plus Bevacizumab in Refractory Mismatch-repair-proficient (pMMR) or Microsatellite-stable (MSS) Metastatic Colorectal Cancer (CombiCoR-Vax)","CombiCoR-Vax","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent.\n* Histologically confirmed pMMR or MSS mCRC\n* Male or female, aged ≥ 18 years\n* Life expectancy greater than 12 weeks\n* ECOG performance status \\\u003C2\n* Patient suitable for the collection of biological material from leukapheresis: negative serological tests (HIV, HBV, HCV, Treponema pallidum); normal cardiological parameters (12-lead ECG and echocardiogram); evaluation by transfusionist to exclude possible contraindications to leukapheresis; recovered (grade 1 or less by CTCAE 5.0) from all the adverse events related to previous treatments.Exclusion Criteria:\n* Patients must have measurable disease by RECIST v 1.1 criteria on CT (or MRI) scan of the chest, abdomen and pelvis. See section 9.2 and Appendix D for the evaluation of measurable disease.\n* Prior treatment with 1-2 chemotherapy regimens in an advanced setting, including (if not contraindicated) fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and\u002For anti-EGFR monoclonal antibody for RAS wild-type tumors.\n* Patients must have normal organ and marrow function as defined below:\n\nleukocytes \\>3,000\u002FμL, absolute neutrophil count \\>1,500\u002FμL, platelets \\>100,000\u002FμL, total bilirubin \\\u003C 1.5 X institutional upper limit of normal (ULN), AST(SGOT)\u002FALT(SGPT) \\\u003C2.5 X ULN, creatinine \\\u003C 1.5 X ULN OR creatinine clearance \\>30 mL\u002Fmin\u002F1.73 m2\n\n* The autologous surgical specimen needed for vaccine manufacturing must have been collected and sent to the Somatic Cell Therapy Lab of IRCCS IRST and must fulfill all the acceptance criteria prescribed by the GMP procedures\n* Recovery (grade 1 or less by CTCAE 5.0) from all the adverse events related to previous surgery.\n* A female participant is eligible to participate if she is not pregnant and not breastfeeding. Female patients of childbearing potential and all male patients must accept and be compliant with a highly effective contraceptive method\n* Participant is willing and able to give informed consent for participation in the study.\n\nExclusion Criteria:\n\nThe participant may not enter the study if ANY of the following apply:\n\n* Prior treatment with FTD\u002FTPI for mCRC\n* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Participation in another clinical trial with any investigational agents within 30 days prior to study screening.\n* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pembrolizumab, FTD\u002FTPI, Bevacizumab or components of the DC vaccine.\n* History of congenital or acquired immunodeficiency, including history of organ transplantation.\n* Any active inflammatory or autoimmune disease requiring systemic steroids or other immunomodulatory agents\n* Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix).",{"count":252,"type":21},36,[90],"Single-arm, open-label, multicenter phase 2 clinical trial evaluating the clinical and the immunological activity of an innovative strategy with an induction combo immunotherapy (Pembrolizumab plus DC Vaccine) followed by a maintenance chemotherapy (FTD\u002FTPI plus Bevacizumab) in patients with refractory MSS\u002FpMMR metastatic colorectal cancer.",[256,257,258],"Colorectal Cancer Metastatic","Microsatellite Stable Colorectal Carcinoma","Refractory Mismatch-repair-proficient (pMMR) Metastatic Colorectal Cancer","2025-01-24",{"date":261,"type":42},"2025-01-28",{"date":263,"type":42},"2025-01-07",{"date":265,"type":21},"2026-09-01",{"name":48,"class":49},{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":275,"minAge":276,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":213},"100407833","what-is-the-best-interval-to-screen-women-45-49-and-70-74-for-breast-cancer-100407833","NCT04590560","What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer?","What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer","MISS","Inclusion Criteria:\n\n1. Women invited for their first or second mammography (45 or 46 y\u002Fo) presenting for screening;\n2. Willingness and ability to comply with scheduled visits;\n3. Written informed consent obtained prior to performing any protocol-related procedures.\n\nExclusion Criteria:\n\n1. Pregnancy status;\n2. Personal history of prior breast carcinoma, either invasive or ductal carcinoma in situ (DCIS) diagnosis;\n3. Ascertained heredo-familial risk according to the standard family history used in screening programs;\n4. Participation in another clinical trial on BC screening;\n5. Inability to provide signed informed consent.","FEMALE","45 Years","49 Years",{"count":279,"type":21},60000,[281],"NA","Italian, multicenter, study aimed at defining the best interval for screening women 45-49 and 70-74 years for Breast Cancer (BC). This research project includes (1) a controlled, prospective randomized non-inferiority trial to determine the optimal screening interval for women aged 45-49, with and without high mammographic density, (2) a retrospective data collection, with the same purpose, on screening performed by women aged 70-74, and (3) a qualitative research to define the best communication strategy.",[284],"Breast Cancer",[286],"Breast cancer, screening, diagnosis, mammography","2024-12-04",{"date":289,"type":42},"2024-12-09",{"date":291,"type":42},"2020-02-06",{"date":293,"type":21},"2026-02",{"name":48,"class":49},{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":302,"enrollmentInfo":303,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":305,"conditions":306,"keywords":308,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},"100427200","integrative-analysis-of-tumor-microenvironment-immunity-and-patient-expectation-for-personalized-response-prediction-in-gastric-cancer-100427200","NCT04842916","InteGRAtive Analysis of TuMor, Microenvironment, ImmunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer","GRAMMY","Inclusion Criteria:\n\n* Patients with diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach (GC) or the gastric-esophageal junction (GEJ) treated with the standard regimens (5-Fluoro-Uracil or Capecitabine + Oxaliplatin +\u002F- Docetaxel)\n* Participant is willing and able to give informed consent for participation in the study (prospective and retrospective cohort) or Substitutive Informed Consent Declaration Form will be subscribed by the PI for patients that are not reachable\n* Male or Female, aged \\>18 years\n* Availability of tissue samples and clinico-pathological data for retrospective cohort\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Early Gastric Cancer and T2 (if N0)\n* Linitis plastica\n* Positive peritoneal cytology or peritoneal involvement\n* Distant metastases\n* Patient refusal to participate\n* Patient refusal to the use of their own samples for research\n* Patient withdrawing from treatment plan whilst under therapy due to patient co-morbidities or failure to comply with clinical counselling\n* Patients with underlying pathologies rendering sampling of biological material either as endangering patient's clinical status or as unusable\n* Patients with mental illness hindering the capacity to provide precise information in questionnaires or successfully comply with caregiver's recommendations","85 Years",{"count":304,"type":21},250,"Multicentric, exploratory, non-pharmacologic, retrospective\u002Fprospective, translational study aiming to identify the molecular, cellular and psychological-sociological variables predictive of response to chemotherapy in gastric cancer patients.",[307],"Gastric Cancer",[309],"Gastric cancer, Chemotherapy, Response, Personalized medicine","2024-11-19",{"date":312,"type":42},"2024-11-21",{"date":314,"type":42},"2020-09-22",{"date":316,"type":21},"2027-05-22",{"name":48,"class":49},5,{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":275,"minAge":18,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":22,"phases":329,"briefSummary":330,"conditions":331,"keywords":333,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":135},"100498602","phase-2-partial-breast-re-irradiation-in-women-in-women-with-locally-recurrent-breast-cancer-previously-treated-with-conservative-surgery-and-whole-breast-irradiation-100498602","NCT05772390","Partial Breast Re-irradiation in Women in Women with Locally Recurrent Breast Cancer Previously Treated with Conservative Surgery and Whole Breast Irradiation","Partial Breast Re-irradiation in Women with Locally Recurrent Breast Cancer Previously Treated with Conservative Surgery and Whole Breast Irradiation: a Prospective Phase II Clinical Study","PBReI","Inclusion Criteria:\n\n1. Isolated ipsilateral unifocal breast lesions;\n2. Histologically confirmed invasive breast carcinoma or carcinoma in situ;\n3. Limited size (\\< 2 cm) without evidence of skin involvement;\n4. Negative histologic margins of resection;\n5. Negative axillary lymph nodes;\n6. No synchronous distant metastases;\n7. Bilateral breast mammogram or MRI within 120 days prior to study entry;\n8. For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan (if clinically relevant);\n9. ≥ 24 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence;\n10. Female, aged \\>18 years;\n11. Life expectancy of greater than 12 months;\n12. ECOG performance status \\<2;\n13. Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 4 months thereafter;\n14. Participant is willing and able to give informed consent for participation in the study;\n\nExclusion Criteria:\n\n1. Regional recurrences (axillary, supraclavicular);\n2. Positive histologic margins at resection;\n3. Metastatic disease;\n4. Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment;\n5. Known pathogenic mutation of BRCA1, BRCA2 or TP53 gene;\n6. Patients who had chemotherapy within 2 weeks prior to study RT;\n7. Participation in another clinical trial with any investigational agents within 30 days prior to study screening;\n8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements;\n9. Significant comorbidity precluding RT for breast cancer (cardiovascular or pulmonary disease, sclerodermia, systemic lupus erythematosus);\n10. Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma of the skin and in situ carcinoma of the uterine cervix, endometrium or colon);\n11. Inaccessibility for follow-up;",{"count":328,"type":21},68,[90],"A prospective study of partial breast re-irradiation in patients with local recurrence of breast cancer",[284,332],"Recurrent",[334,335,336],"Partial re-irradiation","recurrent breast cancer","conservative surgery","2024-09-17",{"date":339,"type":42},"2024-09-19",{"date":341,"type":42},"2023-03-31",{"date":343,"type":21},"2032-03",{"name":48,"class":49},{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":22,"phases":355,"briefSummary":356,"conditions":357,"keywords":362,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":368,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":135},"100375248","phase-2-a-phase-ii-study-on-adjuvant-vaccination-with-dendritic-cells-loaded-with-autologous-tumor-homogenate-in-resected-stage-iv-rare-cancers-100375248","NCT04166006","A Phase II Study on Adjuvant Vaccination with Dendritic Cells Loaded with Autologous Tumor Homogenate in Resected Stage IV Rare Cancers.","A Phase II Study on Adjuvant Vaccination with Dendritic Cells Loaded with Autologous Tumor Homogenate in Resected Stage IV Rare Cancers: Head&Neck (H&N), Neuroendocrine Tumors (NET) and Soft Tissue Sarcoma (STS).","RaC-Ad","Inclusion Criteria:\n\n1. Patients must have histologically confirmed stage IV Head\\&Neck Squamous Cell Carcinoma (HNSCC), NeuroEndocrine Tumors (NET) or Soft Tissue Sarcoma (STS) surgically treated with radical intent.\n2. The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab and must fulfil all the acceptance criteria prescribed by the Good Manufactory Practice (GMP) procedures.\n3. The patient must be disease-free, as assessed by CT scan or MRI of the chest, abdomen, pelvis performed within 60 days before enrolment. If the resected lesions occurred in other sites, these must be also included in the baseline CT scan and in all the subsequent evaluations.\n4. Patients disease-free candidates for only observation as per clinical practice (no standard treatment is available after surgery)\n5. The patient must have recovered from all the adverse events related to previous surgery.\n6. Age ≥18 years.\n7. Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1.\n8. Patient must have acceptable organ function, defined as:\n\n   1. Haemoglobin \\>10 g\u002Fdl\n   2. White blood cells ≥3000\u002Fμl.\n   3. Absolute neutrophil count ≥1500\u002Fμl.\n   4. Platelets≥75000\u002Fμl.\n   5. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C3 times the upper institutional reference level.\n   6. Total bilirubin \\\u003C1.5 times the upper institutional reference level.\n   7. Serum creatinine \\\u003C1.5 times the upper institutional reference level.\n9. Patients aged 70 years or older must have left ventricular ejection fraction not lower than 55% as assessed by echocardiography.\n10. Female patients of childbearing potential and all male patients must accept and be compliant with an highly effective contraceptive method (i.e. with a failure rate of \\\u003C1% per year: double barrier method, one barrier method plus spermicidal, intrauterine device, or oral contraception) from informed consent signature and up to three months after end of study. For this purpose are considered of childbearing potential all female subjects after puberty unless they are post-menopausal for at least two years or are surgically sterile. Complete abstinence from sexual intercourses is acceptable if patients' lifestyle guarantees his\u002Fher strict compliance with this prescription in the judgement of the Investigator.\n11. The patient is willing and able to give written informed consent for the study.\n\nExclusion Criteria:\n\n1. Patients with residual disease after surgery. Marginal resection of any lesion in the absence of clinically evident residual disease is acceptable.\n2. Patient who completed surgery more than 90 days before study enrolment.\n3. History of other neoplastic diseases in the previous 5 years, except basal cell carcinoma of the skin and in situ carcinoma of the cervix uteri treated with curative surgery.\n4. History of congenital or acquired immunodeficiency, including history of organ transplantation.\n5. Any positivity for the serologic markers of hepatitis B virus (HBV) (including at least anti- Hepatitis B surface antibodies (HBs) and hepatitis B core (HBc) antibodies, hepatitis C virus (HCV), HIV or Treponema pallidum. The serologic tests must have been performed within 30 days before any GMP-regulated activity (i.e. surgical resection and leukapheresis). The sole positivity for antibodies against the HBV surface antigen (i.e.\n\n   with all other HBV markers negative) is indicative of previous HBV vaccination and therefore is acceptable.\n6. Female patients who are pregnant or nursing.\n7. Participation in another clinical trial with any investigational agent within 30 days prior to study screening.\n8. Any active inflammatory or autoimmune disease requiring systemic steroids or other immunomodulatory agents as detailed in section 6.4, or potentially requiring such treatments during the study treatment in the judgement of the Investigator.\n9. Any clinical condition that, in the opinion of the Investigator or the Transfusion Medicine specialist, is a contraindication to leukapheresis. In addition, all patients aged 70 or older must be evaluated by a cardiology specialist before the procedure to exclude any clinically relevant cardiac condition and any grade 3-4 cardiac arrhythmia, even if asymptomatic.\n10. Any uncontrolled serious intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations potentially impacting patient safety and compliance in the opinion of the Investigator.\n11. Refusal of giving written informed consent.",{"count":354,"type":21},51,[90],"Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV rare cancers (In Head\u002FNeck tumors (H\\&N), NEuroendocrine Tumors (NET) and Soft Tissue Sarcomas (STS).",[358,359,360,361,119],"Head Neck Tumors","Neuroendocrine Tumors","Soft Tissue Sarcoma","Rare Cancer",[358,359,360,363,364,365,366,367],"rare cancer","vaccination","autologous dendritic cells","adjuvant","Interleukin-2",{"date":339,"type":42},{"date":370,"type":42},"2019-12-12",{"date":372,"type":21},"2031-12",{"name":48,"class":49},{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":17,"minAge":382,"maxAge":4,"enrollmentInfo":383,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":390,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":398,"locationsCount":104},"100279612","phase-2-vaccination-with-autologous-dendritic-cells-loaded-with-autologous-tumour-homogenate-after-curative-resection-for-stage-iv-colorectal-cancer-100279612","NCT02919644","Vaccination with Autologous Dendritic Cells Loaded with Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer.","Vaccination with Autologous Dendritic Cells Loaded with Autologous Tumour Homogenate After Curative Resection for Stage IV Colorectal Cancer: a Phase II Study","COREVAX-1","Inclusion Criteria:\n\n1. Patients must have histologically confirmed stage IV colorectal cancer surgically treated with radical intent.\n2. The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab of Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST IRCCS) and must fulfil all the acceptance criteria prescribed by the Good Manufacturing practise (GMP) procedures.\n3. The patient must be disease-free, as assessed by CT scan or MRI of the chest, abdomen, pelvis performed within 60 days before enrolment. If the resected lesions had occurred in other sites, these must be also included in the baseline CT scan and in all the subsequent evaluations.\n4. The patient must have recovered (grade 1 or less by CTCAE 4.0) from all the adverse events related to previous surgery.\n5. Age \\>18 years.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n7. Patient must have acceptable organ function, defined as:\n\n   1. Haemoglobin \\>10 g\u002Fdl\n   2. White blood cells ≥4000\u002Fμl.\n   3. Absolute neutrophil count \\>1500\u002Fμl.\n   4. Platelets ≥100000\u002Fμl.\n   5. aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) \\\u003C3 times the upper institutional reference level.\n   6. Total bilirubin \\\u003C1.5 times the upper institutional reference level.\n   7. Serum creatinine \\\u003C1.5 times the upper institutional reference level.\n8. Patients aged 70 years or older must have left ventricular ejection fraction not lower than 55% as assessed by echocardiography.\n9. Female patients of childbearing potential and all male patients must accept and be compliant with an highly effective contraceptive method (i.e. with a failure rate of \\\u003C1% per year: double barrier method, one barrier method plus spermicidal, intrauterine device, or oral contraception) from informed consent signature and up to three months after end of study. For this purpose are considered of childbearing potential all female subjects after puberty unless they are post-menopausal for at least two years or are surgically sterile. Complete abstinence from sexual intercourses is acceptable if patients' lifestyle guarantees his\u002Fher strict compliance with this prescription in the judgement of the Investigator.\n10. The patient is willing and able to give written informed consent for the study.\n\nExclusion Criteria:\n\n1. Patients with residual disease after surgery. Marginal resection of any lesion in the absence of clinically evident residual disease is acceptable.\n2. Patients who relapsed within 6 months since primary treatment of stage I-III colorectal cancer. If adjuvant chemotherapy had been administered, the term must be computed since last chemotherapy dose.\n3. Patient who completed surgery more than 60 days before study enrolment.\n4. History of other neoplastic diseases in the previous 5 years, except basal cell carcinoma of the skin and in situ carcinoma of the cervix uteri treated with curative surgery.\n5. History of congenital or acquired immunodeficiency, including history of organ transplantation.\n6. Any positivity for the serologic markers of hepatitis B virus (HBV) (including at least anti-HBs antibodies and anti-hepatitis B core (HBc) antibodies), hepatitis C virus (HCV), HIV or Treponema pallidum. The serologic tests must have been performed within 30 days before any GMP-regulated activity (i.e. surgical resection and leukapheresis). The sole positivity for antibodies against the HBV S antigen (i.e. with all other HBV markers negative) is indicative of previous HBV vaccination and therefore is acceptable.\n7. Female patients who are pregnant or nursing.\n8. Patients undergone surgery after preoperatory chemotherapy with a fluoropyrimidine plus oxaliplatin, unless they are not candidate for postoperatory chemotherapy with the same schedule in the opinion of the Investigator (e.g. for unacceptable toxicity) or refuse completion of the perioperatory treatment.\n9. Participation in another clinical trial with any investigational agent within 30 days prior to study screening.\n10. Any active inflammatory or autoimmune disease requiring systemic steroids or other immunomodulatory agents as detailed in section 6.4, or potentially requiring such treatments during the study treatment in the judgement of the Investigator.\n11. Any clinical condition that, in the opinion of the Investigator or the Transfusion Medicine specialist, is a contraindication to leukapheresis. In addition, all patients aged 70 or older must be evaluated by a cardiology specialist before the procedure to exclude any clinically relevant cardiac condition and any grade 3-4 cardiac arrhythmia, even if asymptomatic.\n12. Any clinical condition that, in the opinion of the Investigator, contraindicates the subcutaneous administration of low-dose IL-2 as per protocol (see section 6.2 for details).\n13. Any uncontrolled serious intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations potentially impacting patient safety and compliance in the opinion of the Investigator.\n14. Refusal of giving written informed consent.","19 Years",{"count":384,"type":21},19,[90],"Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer",[388,389],"Stage IV Colorectal Cancer","Curative Resection",[364,365,391,392,393],"autologous tumour homogenate","curative resection","stage IV colorectal cancer",{"date":339,"type":42},{"date":396,"type":42},"2016-12-02",{"date":372,"type":21},{"name":48,"class":49},{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":104},"100519569","phase-2-receptor-radionuclide-therapy-with-177lu-dotatoc-100519569","NCT06045260","\"Receptor Radionuclide Therapy With 177Lu-DOTATOC","\"Receptor Radionuclide Therapy With 177Lu-DOTATOC (177Lu-edotreotide or 177Lu-octreotide) in SSTR Positive Patients: a Multicenter, Prospective, Phase II Trial\"","LUFOR","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Patients must have histologically or cytologically confirmation of neuroendocrine tumors or any other tumor histology type documented as sst2-positive, that may benefit from receptor radionuclide therapy and for which there are not any other effective treatments, included locoregional methods of control for PPGLs\u002Fpheochromocytoma. For cerebral and PPGLs sst2- positive tumors, if biopsy is no feasible for technical reason or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest oncological lesion confirming the 68Ga PET-CT dota-peptide SSTr2 positivity.\n3. Measurable disease according to RECIST 1.1 criteria also patients without measurable but with evaluable disease can be enrolled.\n4. Any disease stage is allowed. Patients with documented disease will be admitted to the therapeutic phase only if the diagnostic PET\u002FCT 68Ga-peptide images demonstrate a significant uptake in the tumour, according to the adapted Krenning Scale. Only patients with a greater caption (Grade 3 or 4) in most of the lesions will be admitted.\n5. Patients with progressive disease in pre-study period (PD within the last 12 months), refractory to conventional standard treatments; clinical progression is allowed.\n6. Patients with or without concurrent therapy with somatostatin analogs. It will be maintained the same dose of the SSA analogs as at the time of demonstrated disease progression.\n7. Life expectancy of greater than 6 months.\n8. ECOG performance status \\\u003C2.\n9. Adequate haematological, liver and renal function: haemoglobin \\>= 9 g\u002FdL, absolute neutrophil count (ANC) \\>= 1.5 x 109 \u002FL, platelets \\>= 100 x 109 \u002FL, bilirubin ≤1.5 X UNL (upper normal limit), ALT and AST \\\u003C2.5 X UNL (\\\u003C 5 X UNL in presence of liver metastases), creatinine \\\u003C 2 mg\u002FdL and\u002For eGFR or creatinine clearance \\> 50 ml\u002Fmin.\n10. If female of childbearing potential highly effective birth control methods, according to guideline \"Recommendation related to contraception and pregnancy testing in clinical trials\", (2014\\_09\\_15 section 4.1) are mandatory (see Appendix F). Highly effective birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug. A negative serum pregnancy test should be performed the same day the treatment is started at any cycle. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required (established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), for more than 6 months (see Appendix F).\n11. Participant is willing and able to give informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy.\n2. Known hypersensitivity to lutetium-177 (177Lu), edotreotide, DOTA or components of the formulation or other radiolabeled peptide agents.\n3. Known hypersensitivity to lysine, arginine, or any excipient of the nephroprotective aminoacids given concurrently with the lutetium (177Lu) edotreotide infusion;\n4. Patients treated with prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow.\n5. Patients treated with previous PRRT with an absorbed dose to the kidney more than 23 Gy and more than 1.8 Gy for the bone marrow or as surrogate of dosimetry (13).\n6. Patients which are included in the indication of LUTATHERA®(9).\n7. All acute toxic effects of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to a grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE).\n8. ECOG performance status \\>2.\n9. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.\n10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n11. Pregnant or breastfeeding women are excluded from the present study.",{"count":408,"type":21},100,[90],"Peptide receptor radionuclide therapy (PRRT) may be recommended in G1- G2 GEP-NET patients with disease progression on somatostatine analogues therapy (LUTATHERA®). However, there are several diseases, including neuroendocrine neoplasia not originating from the digestive tract, for which the efficacy of PRRT has already been demonstrated, but which are not currently within the indications of LUTATHERA and therefore cannot benefit from it (i.e. bronchopulmonary, ovarian, renal NETs and neuroendocrine carcinomas). Moreover, the role of PRRT is also accepted in Pheochromocytomas and paragangliomas (PPGLs), Meningiomas, but also as a salvage therapy in pre-treated NET pts, and other SSTR-positive malignancies (Lymphomas, Gliomas…). Least explored among radiopharmaceuticals for SSTR-positive tumors is 177Lu-DOTATOC. This study aims to investigate the efficacy and safety of lutetium (177Lu) edotreotide (Lu-Dotatoc) on all the above-mentioned diseases that could benefit from receptor radionuclide therapy. We believe that this study, which will involve only patients outside the indication of LUTATHERA, will expand the current knowledge of radionuclide receptor therapy with 177Lu- DOTATOC, particularly with regard to objective response and safety parameters, and may consolidate its in the management of these diseases.",[359,412,413],"Paraganglioma","Pheochromocytoma","2024-08-09",{"date":416,"type":42},"2024-08-13",{"date":418,"type":42},"2023-09-13",{"date":420,"type":21},"2027-01",{"name":48,"class":49},{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":430,"targetDuration":432,"studyType":62,"phases":4,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":444},"100544331","national-database-of-bone-metastases-100544331","NCT06367491","National Database of Bone Metastases","Banca Dati Nazionale Metastasi Ossee","BDMO","Inclusion Criteria:\n\n* Radiological and\u002For histological diagnosis of bone metastasis from histologically established solid tumor\n* Males or females aged \\>= 18 years\n* Informed consent\n\nExclusion Criteria:\n\n* Not applicable",{"count":431,"type":21},800,"20 Years","BDMO is an Italian multicentre, observational, prospective study that collects data from all patients with bone metastases referred to each participating centre, using an on-line software 'tailor-made' for data collection.",[435],"Bone Metastases","2024-04-11",{"date":438,"type":42},"2024-04-16",{"date":440,"type":42},"2013-10-08",{"date":442,"type":21},"2030-01-01",{"name":48,"class":49},30,""]