[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-grade-serous-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-grade-serous-carcinoma":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,59,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100571905","risk-reducing-strategies-including-fimbriectomy-in-women-with-a-germline-mutation-predisposing-to-ovarian-or-pelvic-cancer-100571905",false,"NCT06726330","Risk-reducing Strategies, Including Fimbriectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer","Evaluation of Risk Control of Advanced Stage Tubo-ovarian or Primary Peritoneal Carcinoma Associated With Ovarian Carcinoma Risk-reducing Strategies, Including Fimbriectomy With Delayed Oophorectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer","FIMBRIMENOP","Inclusion Criteria:\n\n1. Woman between 35 to 50 years\n2. Addressed to or followed in an oncogenetic counselling\n3. Identified risk of tubo-ovarian or primary peritoneal carcinoma based on mutational status (BRCA1, BRCA 2, RAD51C, RAD51D, PALB2). The list of considered mutations may be extended during the study.\n4. Written informed consent\n5. Patient covered by the French \"Social Security\"\n\nExclusion Criteria:\n\n1. Prior bilateral oophorectomy and\u002For bilateral salpingectomy for any reason (prophylactic surgery or other)\n2. Personal history of ovarian, fallopian tube or primary peritoneal cancer\n3. Menopause defined by\n\n   • In women without prior chemotherapy If no prior hysterectomy: the absence of menses for at least 12 months, or FSH \\> 20 UI\u002FL with low estrogen level with no identified gynecological or endocrine explanation. Amenorrhea related to an intrauterine device, vaginal ring or estrogen-progestin pill will not be considered as menopause.\n\n   If prior hysterectomy: FSH \\>20 UI\u002FL with low estrogen level (with or without vasomotor symptoms, genitourinary symptoms)\n   * In women with prior chemotherapy: the absence of menses for at least 24 months\n   * In all women with progesterone-loaded intra-uterine device (IUD): FSH \\> 20 UI\u002FL with low estrogen level\n4. Inability to comply with medical follow-up of the trial (geographical, social or psychological reasons)\n5. Patient under guardianship or curatorship","FEMALE","35 Years","50 Years",{"count":21,"type":22},1100,"ESTIMATED","INTERVENTIONAL",[25],"NA","• FIMBRIMENOP-2402 study aims to evaluate the long-term management of cancer risks in premenopausal women who have a genetic predisposition to tubo-ovarian or primary peritoneal carcinoma, such as mutations in BRCA1, BRCA2, RAD51C, RAD51D, or PALB2 genes. This study offers an alternative to standard preventive surgery (bilateral salpingo-oophorectomy or BSO) by exploring the use of fimbriectomy (removal of the fallopian tube's fimbria) followed by delayed oophorectomy (removal of ovaries at menopause).\n\nIt's a pragmatic multicenter trial conducted across various medical centers, employing a non-randomized controlled preference design to compare two preventive surgical strategies:\n\n1. Fimbriectomy followed by delayed oophorectomy (F-DO).\n2. Bilateral salpingo-oophorectomy (BSO).\n\nThe primary objective is to compare the long-term efficacy of two preventive surgical strategies :\n\n1. Fimbriectomy followed by delayed oophorectomy (F-DO).\n2. Bilateral salpingo-oophorectomy (BSO).\n\nAs for the design of the study, participants choose their preferred surgical strategy during or after oncogenetic counseling, ensuring patient autonomy in decision-making.\n\n• Follow-Up: Long-term follow-up includes clinical assessments, data collection from medical networks, and integration with national health databases to track outcomes up to the age of 70.\n\nThis is the first French comparative study in real-world settings and is classified as interventional research (RIPH1) under French regulations, given the need to validate fimbriectomy efficacy.",[28,29,30,31,32],"Tubo-ovarian Carcinoma","High-grade Serous Carcinoma","Primary Peritoneal Carcinoma Stage III","Primary Peritoneal Carcinoma Stage IV","Primary Peritoneal Carcinoma",[34,35,36,37,38,39,40,41,42,43,44,45],"Tubo-ovarian carcinoma","Primary peritoneal carcinoma","BRCA1\u002F2 mutations","RAD51C\u002FD mutations","PALB2 mutation","Preventive surgery","Fimbriectomy","Bilateral salpingo-oophorectomy","BSO","Cancer prevention","Premenopausal women","Genetic predisposition to cancer","NOT_YET_RECRUITING","2026-03-16",{"date":49,"type":50},"2026-03-17","ACTUAL",{"date":52,"type":22},"2027-03",{"date":54,"type":22},"2071-03",{"name":56,"class":57},"Centre Oscar Lambret","OTHER",23,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":23,"phases":70,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100427509","multi-layer-data-to-improve-diagnosis-predict-therapy-resistance-and-suggest-targeted-therapies-in-hgsoc-100427509","NCT04846933","Multi-layer Data to Improve Diagnosis, Predict Therapy Resistance and Suggest Targeted Therapies in HGSOC","Integration of Multiple Data Levels to Improve Diagnosis, Predict Treatment Response and Suggest Targets to Overcome Therapy Resistance in High-grade Serous Ovarian Cancer","DECIDER","Inclusion Criteria:\n\n* Patients with a suspected ovarian cancer diagnosis treated at the Turku University Hospital\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Age \\\u003C18 years, too poor condition for active treatment (surgery, chemotherapy)\n* FDG PET\u002FCT scan is not performed for patients with diabetes mellitus and poor glucose balance.","18 Years",{"count":69,"type":22},200,[25],"Chemotherapy resistance is the greatest contributor to mortality in advanced cancers and severe challenges remain in finding effective treatment modalities to cancer patients with metastasized and relapsed disease. High-grade serous ovarian cancer (HGSOC) is typically diagnosed at a stage where the disease is already widely spread to the abdomen and current standard of practice treatment consists of surgery followed by platinum-taxane based chemotherapy and maintenance therapy. While 90% of HGSOC patients show no clinically detectable signs of cancer after surgery and chemotherapy, only 43% of the patients are alive five years after diagnosis because of chemoresistant cancer.\n\nThis prospective, observational trial focuses on revealing major mechanisms causing chemoresistance in HGSOG patients and derive personalized treatment regimens for chemotherapy resistant HGSOC patients. The investigators recruit newly diagnosed advanced stage HGSOC patients who are then thoroughly followed during their cancer treatment. Longitudinal sampling includes digitalized H\\&E stained histology slides mainly collected during routine diagnostics, fresh tumor \\& ascites samples for next-generation sequencing\u002Fproteomics (WGS, RNA-seq, DNA-methylation, ATAC-seq, ChIP-seq, mass cytometry, etc.) and ex vivo experiments, plasma samples for circulating tumor DNA (ctDNA) analyses. Broad range of clinical parameters such as laboratory and radiologic parameters (e.g., FDG PET\u002FCT), given cancer treatments and their outcomes are collected. Radiomic analyses are performed to PET\u002FCT and CT scans. Long-term patient derived organoid lines are established from fresh tumor tissues. Actionable genomic alterations are searched.\n\nThe general objective is to establish a clinically useful precision oncology approach based on multi-level data collected in longitudinal setting, and translate the most potent and validated discoveries into clinical use. DECIDER project will produce AI-powered diagnostic tools, cutting-edge software platforms for clinical decision-making, novel data analysis \\& integration methods, and high-throughput ex vivo drug screening approaches.",[73,74],"High Grade Ovarian Serous Adenocarcinoma","High Grade Serous Carcinoma",[76,77,78,79,80,81,82,83,84,85,86,87,88,89],"chemoresistance","personalized medicine","WGS","ctDNA","digital pathology","FDG PET\u002FCT","bioinformatics","AI","ovarian cancer","tumor evolution","artificial intelligence","organoid","DNA methylation","radiomics","RECRUITING","2025-01-14",{"date":93,"type":50},"2025-01-16",{"date":95,"type":50},"2012-02-01",{"date":97,"type":22},"2029-12",{"name":99,"class":100},"Turku University Hospital","OTHER_GOV",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":101},"100445447","phase-2-adaptive-chemotherapy-for-ovarian-cancer-in-patients-with-replased-platinum-sensitive-high-grade-serous-or-high-grade-endometrioid-ovarian-cancer-100445447","NCT05080556","Adaptive ChemoTherapy for Ovarian Cancer in Patients With Replased Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer","A Multicentre Phase II Randomised Controlled Trial to Evaluate the Efficacy of Adaptive Therapy (AT) With Carboplatin, Based on Changes in CA125, in Patients With Relapsed Platinum-sensitive High Grade Serous or High Grade Endometrioid Ovarian Cancer","ACTOv","Inclusion Criteria:\n\n1. Female patients aged ≥18 years\n2. ECOG performance status 0-2\n3. Histologically proven diagnosis of high grade serous or high grade endometrioid carcinoma of the ovary, fallopian tube or peritoneum\n4. Most recent regimen must have included platinum (cisplatin or carboplatin)\n5. Must have previously received a PARP inhibitor\n6. 6\\. Must have responded to most recent platinum treatment by CT or MRI or by GCIG CA125 response criteria\n7. Pre-trial CT or MRI-confirmed disease relapse ≥ 6 months after day 1 of the last cycle of platinum-containing chemotherapy (cisplatin or carboplatin) and requiring treatment with further platinum-based chemotherapy\n8. Measurable disease by RECIST v1.1 on a CT scan conducted within 28 days prior to randomisation (Patient with non-measurable disease could be eligible if they meet GCIG CA125 progression criteria)\n9. CA125 ≥ 100iU\u002Fl at screening\n10. Agree to provide additional research blood samples at the same time as blood draws prior to each carboplatin treatment, 6-weekly during surveillance and at 12- weekly follow-up visit\n11. Expected to be able to commence treatment within 28 days post randomisation\n12. Adequate bone marrow function\n13. Adequate liver function\n14. Adequate renal function\n15. Postmenopausal or women of child-bearing potential (WOCBP) must agree to have an urine or serum pregnancy test at screening for evidence of non-childbearing status and prior to trial treatment and use adequate contraception for duration of trial\n16. Willing and able to give consent and able to comply with treatment and follow up schedule\n\nExclusion Criteria:\n\n1. Non-epithelial ovarian cancer, carcinosarcoma, low-grade serous and endometrioid carcinomas, mucinous \\& clear-cell carcinomas\n2. Patients requiring treatment with combination chemotherapy regimens\n3. Patients with a known hypersensitivity to carboplatin\n4. Persisting ≥ grade 2 CTCAE v5 adverse events\u002F toxicity (except alopecia and neuropathy) from previous anti-cancer treatment.\n5. Treatment with any other investigational agent, or participation in another interventional clinical trial within 28 days prior to randomisation.\n6. Major surgery within 14 days before anticipated start of treatment and patients must have recovered from any effects of major surgery.\n7. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicated the use of an investigation drug or puts the patients at high risk for treatment-related complications.\n8. Other psychological, psychiatric, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.\n9. Malignancy treated within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, Stage 1, grade 1 endometrial carcinoma.\n10. Patients with symptomatic uncontrolled brain or meningeal metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.\n11. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days prior to randomisation.\n12. Pregnant or breast-feeding women are excluded. Women of childbearing potential will be excluded unless effective methods of contraception are used from signing of the informed consent, throughout the period of taking study treatment and for at least 6 months after last dose of trial drug(s).\n13. Inability to attend or comply with treatment or follow-up scheduling.",{"count":111,"type":22},80,[113],"PHASE2","ACTOv will compare standard 3-weekly carboplatin (AUC5), to carboplatin delivered according to an AT regimen. The AT regimen will modify carboplatin dose according to changes in the clinical-standard serum biomarker CA125 as a proxy measure of total tumour burden and an individual patient's response to the most recent chemotherapy treatment. AT could prolong sensitivity to carboplatin and extend tumour control, while simultaneously reducing chemotherapy dose and drug-induced toxicity. Carboplatin is a low cost and low toxicity drug that has an enduring and central role in ovarian cancer treatment.",[116,117,118,119,120,74,121],"Ovarian Cancer","Relapsed Ovarian Cancer","Fallopian Tube Cancer","Peritoneal Cancer","Endometrioid Carcinoma","Ovary Cancer","2024-04-11",{"date":124,"type":50},"2024-04-12",{"date":126,"type":50},"2023-05-24",{"date":128,"type":22},"2027-11-01",{"name":130,"class":57},"University College, London"]