[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Consorzio Oncotech\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,67],{"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":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100583067","observational-retrospective-and-prospective-non-interventional-multicentre-on-the-use-of-genomic-testing-in-the-management-of-early-stage-hrher2--breast-cancer-100583067",false,"NCT06871501","\"Observational, Retrospective and Prospective, Non-interventional, Multicentre on the Use of Genomic Testing in the Management of Early Stage HR+\u002FHER2- Breast Cancer\"","\"Observational, Retrospective and Prospective, Non-interventional, Multicentre National Registry-based Study to Collect Information on the Use of Genomic Testing in the Management of Early Stage HR+\u002FHER2- Breast Cancer\"","GIM29-GIMOMIC","Inclusion Criteria:\n\n1. . Age ≥ 18 years\n2. PS ECOG 0-1\n3. Histologically confirmed early breast carcinoma with positivity for hormone receptors (ER+ IHC \\>10%) and HER2 negative (IHC value 0 1+ and\u002For FISH not-amplified)\n4. Primary resective surgery for early breast cancer with adequate assessment of lymph node status (sentinel lymph node biopsy or complete axillary dissection), with one of the following diagnostic stages:\n\n   * T1-3, N0, M0\n   * T1-3, pN1mic, M0\n   * T1-3, pN1a, M0\n5. Indication for adjuvant treatment with endocrine therapy (ET) or chemo endocrine therapy (CET), according to the decision of the reference Breast Unit\n6. Meeting the criteria for \"intermediate\" risk, i.e., no \"low\" or \"high\" risk of recurrence, as defined in the ministerial decree of 18\u002F05\u002F21:\n\n   * Low risk defined by at least 5 of the following: G1, T1a-b, KI67 \\\u003C 15, N neg, ER \\> 80%\n   * High risk, defined by at least 4 of the following: G3, T \\> 2, Ki67 \\> 30, N pos, ER \\\u003C 30%\n7. Indication for genomic test (Oncotype DX®, Mammaprint®, PAM50 Prosigna®, Breast Cancer Index®, EndoPredict®) by the Breast Unit\n8. Ability to provide written informed consent to participate in the registry study, approved by the local Ethics Committee.\n9. The patient underwent genomic testing starting from September 2021\n\nExclusion Criteria:\n\n1. Low-risk and High-risk patients as defined in the Ministerial Decree of 18\u002F05\u002F21\n2. ER negative and\u002For HER2 positive tumours\n3. More than 3 lymph nodes involved at clinical\u002Fpathological staging\n4. Invasive tumours \\\u003C2mm evaluated by local pathologists\n5. Previous history of breast cancer\n6. Synchronous breast cancers\n7. Multifocal tumours\n8. Metastatic disease\n9. Contraindications to adjuvant treatments\n10. Performance status (PS ECOG) \\> 1 and \u002F or other clinical factors that would make the patient a candidate and unsuitable for systemic adjuvant treatment or have received an exclusive indication for precautionary hormone therapy as part of the Breast Unit collegial assessment.\n11. Psychiatric diagnosis that may affect the ability to participate in this study","ALL","18 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","The study aims to establish an Italian registry for the implementation of the use of genomic tests in patients with HR +\u002FHER2- breast cancer at intermediate risk of recurrence after the entry into force of the Ministerial Decree of 18\u002F05\u002F2021. The decree has established the reimbursability of genomic testing for breast cancer patients, thereby influencing clinical decision-making and patient management within Breast Units. In addition, the study aims to evaluate the clinical impact of the use of genomic testing on the type of adjuvant treatment, in terms of change of treatment indication by breast units according to the test result.",[25],"Breast Cancer",[25,27],"Genomic testing","NOT_YET_RECRUITING","2025-03-11",{"date":31,"type":32},"2025-03-13","ACTUAL",{"date":34,"type":21},"2025-03",{"date":36,"type":21},"2026-11",{"name":38,"class":39},"Consorzio Oncotech","OTHER",25,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100580355","measure-of-outcomes-in-patients-with-advanced-ovarian-cancer-according-to-homologous-recombination-status-and-matched-therapies-in-a-real-world-scenario-100580355","NCT06836219","Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario","Measure of Outcomes in Patients With Advanced Ovarian Cancer According to Homologous Recombination Status and Matched Therapies in a Real-world Scenario: A Retrospective and Prospective, Multicenter, Two Cohorts Study","BeLIVE","Inclusion Criteria:\n\n* Female, age ≥ 18 years at the time of diagnosis\n* Patients diagnosed with high-grade serous or endometroid ovarian, fallopian tube, or primary peritoneal cancer undergone to Homologous Recombination test with the MyChoice HRD assay, FoundationOne DX assay or another validated HRD test, between January 2021 and January 2026:\n\n  * Patients with HRD score \\> 42 or Loss of Heterozygosity (LOH) score high or defined as HR deficient with other tests and treated with Bevacizumab and Olaparib after first line platinumbased chemotherapy will be retrospectively or prospectively enrolled in Cohort A\n  * Patients with HRD score \\\u003C 42 or Loss of Heterozygosity (LOH) score low or defined as HR proficient with other tests and treated with first line platinum-based chemotherapy with or without bevacizumab or others targeted agents will be retrospectively or prospectively enrolled in Cohort B\n* Patients must be able to understand the study procedures and agree to participate in the study by providing written informed consent.\n\nExclusion Criteria:\n\n* Patients who have not performed a validated Homologous Recombination test on tumor sample.\n* Patients with germline or somatic BRCA 1 or 2 mutations\n* Patients death at the time of inclusion in the current study","FEMALE",{"count":51,"type":21},300,"This is a retrospective and prospective, multicenter, observational, two-cohorts study aimed to evaluate clinical outcomes and safety of patients diagnosed with advanced high grade ovarian cancer whose tumor was tested for the homologous recombination (HR) status using a validated HR deficiency test between January 2021 and January 2026.\n\n* Cohort A: Homologous Recombination Deficient (HRD) ovarian cancer patients treated with Olaparib plus Bevacizumab as maintenance therapies after partial or complete response to first line platinum-based chemotherapy.\n* Cohort B: Homologous Recombination Proficient (HRP) ovarian cancer patients treated as for standard clinical practice at clinician's choice.",[54],"Ovarian Cancer",[54,56],"Homologous Recombination status","RECRUITING","2025-02-14",{"date":60,"type":32},"2025-02-20",{"date":62,"type":32},"2024-09-13",{"date":64,"type":21},"2029-01",{"name":38,"class":39},21,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100502103","phase-2-axitinib-intensification-plus-nivolumab-or-nivolumab-alone-after-nivolumab-plus-ipilimumab-in-mrcc-patients-100502103","NCT05817903","Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients","Phase II Study of Axitinib Intensification Plus Nivolumab Compared to Nivolumab Alone After Induction With Nivolumab Plus Ipilimumab in mRCC Patients Without Previous Complete Response (AxIn Study).","AxIn","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype and candidate to receive nivolumab after nivolumab plus ipilimumab induction as per standard clinical practice.\n2. Completion of the induction of nivolumab and ipilimumab without toxicity ≥ G2 and no complete response or progressive disease.\n3. Male or female subjects aged ≥ 18 years\n4. Available tumor tissue sample.\n5. At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.\n6. Eastern Cooperative Oncology Group performance status 0 or 1.\n7. Adequate organ and bone marrow function based upon meeting all of the following laboratory criteria within 10 days before the start of treatment:\n\n   1. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3 (≥ 1.5 GI\u002FL)\n   2. Platelets ≥ 100,000\u002Fmm3 (≥ 100 GI\u002FL).\n   3. Haemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL).\n   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 3.0 × upper limit of normal.\n   5. Total bilirubin ≤ 1.5 × the upper limit of normal. For subjects with Gilbert's disease ≤ 3 mg\u002FdL (≤ 51.3 µmol\u002FL).\n   6. Serum creatinine ≤ 2.0 × upper limit of normal or calculated creatinine clearance ≥ 30 mL\u002Fmin (≥ 0.5 mL\u002Fsec) using the Cockroft-Gault.\n8. Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.\n9. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 5 months after the last dose of study treatment.\n10. Female subjects of childbearing potential must not be pregnant at screening. Females of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression or other reasons.\n\nExclusion Criteria:\n\n1. Prior treatment with systemic therapy for advanced RCC with the exclusion of the induction of nivolumab and ipilimumab.\n2. Prior adjuvant or neoadjuvant therapy\n3. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis\n4. Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of the start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low-grade prostate cancer with no plans for treatment intervention.\n5. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the start of treatment. Systemic treatment with radionuclides within 6 weeks before the start of treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 3 months before the start of treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of treatment.\n7. Concomitant anticoagulation at therapeutic doses with oral anticoagulants (e.g., warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel).\n8. In past 6 months: myocardial infarction, uncontrolled angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack.\n9. Chronic treatment with corticosteroids or other immunosuppressive agents (with the exception of inhaled or topical corticosteroids or corticosteroids with a daily dosage equivalent ≤ 10 mg prednisone if given for disorders other than renal cell cancer). Subjects with brain metastases requiring systemic corticosteroid are not eligible.\n10. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n    I. Cardiovascular disorders:\n    1. Symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmias.\n    2. Uncontrolled hypertension defined as sustained BP \\> 150 mm Hg systolic or \\> 100 mm Hg diastolic despite optimal antihypertensive treatment.\n    3. Stroke (including TIA), myocardial infarction, or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months before the start of treatment.\n\n    II. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:\n    1. Tumors invading the GI-tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction.\n    2. Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before the start of treatment. Note: Complete healing of an intra-abdominal abscess must be confirmed before the start of treatment.\n\n    III. Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 3 months before the start of treatment.\n\n    IV. Cavitating pulmonary lesion(s) or known endobronchial disease manifestation.\n\n    V. Lesions invading major pulmonary blood vessels.\n\n    VI. Other clinically significant disorders such as:\n    1. Active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)- related illness, or chronic hepatitis B or C infection.\n    2. Serious non-healing wound\u002Fulcer\u002Fbone fracture.\n    3. Malabsorption syndrome.\n    4. Uncompensated\u002Fsymptomatic hypothyroidism.\n    5. Moderate to severe hepatic impairment (Child-Pugh B or C).\n    6. Requirement for hemodialysis or peritoneal dialysis.\n    7. History of solid organ transplantation.\n    8. In past 6 months: deep vein thrombosis or pulmonary embolism.\n    9. History of aneurysms and\u002For artery dissections\n11. Major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 3 months before the start of treatment. Complete wound healing from major surgery must have occurred 1 month before the start of treatment and from minor surgery (e.g., simple excision, tooth extraction) at least 10 days before the start of treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.\n12. Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 msec within 1 month before the start of treatment (see Section 5.5.4 for Fridericia formula). Three ECGs must be performed. If the average of these three consecutive results for QTcF is ≤ 500 msec, the subject meets eligibility in this regard.\n13. Vaccination within 4 weeks of the first dose of nivolumab and while on trials is prohibited except for administration of inactivated vaccines.\n14. Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.\n15. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n16. Has a history of substance abuse or medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.\n17. Has illness or medical conditions that are unstable or could jeopardize the safety of the patient and his or her compliance in the study.\n18. Pregnant or lactating females.\n19. Inability to swallow tablets or capsules.\n20. Previously identified allergy or hypersensitivity to components of the study treatment formulations.\n21. Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.",{"count":76,"type":21},118,"INTERVENTIONAL",[79],"PHASE2","This phase II open label trial randomized patients who completed the induction with nivolumab plus ipilimumab without complete response or progressive disease will be randomized 1:1 to receive axitinib in addition to nivolumab (Arm A) or continue with nivolumab alone (Arm B).Treatment will be continued until progression of disease, unacceptable toxicity, patient's refusal, or physician decision whichever occurred first.",[82],"Metastatic Renal Cell Carcinoma",[84],"mRCC","2023-05-05",{"date":87,"type":32},"2023-05-08",{"date":89,"type":32},"2023-04-18",{"date":91,"type":21},"2027-04-01",{"name":38,"class":39},23,""]