[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atypical-endometrial-hyperplasia-and-endometrial-carcinoma-stage-i\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atypical-endometrial-hyperplasia-and-endometrial-carcinoma-stage-i":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,68],{"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":36,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100628517","phase-4-shape-endo-pilot-randomized-trial-of-multimodal-pre-surgical-optimization-versus-standard-surgery-in-patients-with-obesity-and-early-stage-endometrial-cancer-100628517",false,"NCT07462663","SHAPE-ENDO: Pilot Randomized Trial of Multimodal Pre-Surgical Optimization Versus Standard Surgery in Patients With Obesity and Early-Stage Endometrial Cancer","SHAPE-ENDO (Strategic Hormonal Approach & Prehabilitation in Endometrial Cancer): An Open-Label, Pilot Randomized Clinical Trial Comparing Standard Immediate Surgery Versus a Multimodal Metabolic Optimization and Prehabilitation Strategy Before Surgery in Patients With Atypical Endometrial Hyperplasia or Low-Risk Endometrioid Endometrial Cancer and BMI ≥40 kg\u002Fm²","SHAPE-ENDO","Inclusion Criteria:\n\n* Female participants ≥18 years old.\n* Histologically confirmed atypical endometrial hyperplasia\u002Fendometrial intraepithelial neoplasia (AEH\u002FEIN) or low-risk endometrioid endometrial carcinoma, grade 1 or 2.\n* Disease apparently confined to the uterine corpus, assessed by expert transvaginal ultrasound and\u002For pelvic magnetic resonance imaging.\n* Low- or intermediate-risk disease according to ESGO-ESTRO-ESP 2025 criteria, including presurgical stages IA1, IA2, or IB.\n* Negative or focal lymphovascular space invasion, if available.\n* Favorable molecular profile, if available, including POLE-mutated, p53 wild-type, MMR-deficient, or NSMP estrogen receptor-positive disease.\n* Body mass index ≥40 kg\u002Fm² at inclusion.\n* Considered a candidate for surgical treatment by the multidisciplinary tumor board.\n* Ability to understand and sign written informed consent after receiving oral and written information about the study, including acceptance of random assignment to either standard immediate surgery or the SHAPE-ENDO multimodal pre-surgical optimization strategy.\n\nExclusion Criteria:\n\n* FIGO stage IA3, IC, II, or higher disease.\n* Extensive lymphovascular space invasion, if available.\n* High-risk molecular profile, including p53-abnormal\u002Fmutated disease or NSMP estrogen receptor-negative disease.\n* Non-endometrioid histology, including serous carcinoma, clear-cell carcinoma, carcinosarcoma, mixed histology, or other high-risk histological subtypes.\n* Metastatic disease or suspicion of extrauterine disease.\n* Considered medically inoperable or \"unfit\" for surgery because of severe comorbidity, frailty, anesthetic contraindication, or any other clinical reason contraindicating surgical treatment.\n* Contraindication to GLP-1 receptor agonist therapy or progestin-based hormonal therapy, including levonorgestrel-releasing intrauterine device or oral progestins.\n* Previous pancreatitis, medullary thyroid carcinoma, or multiple endocrine neoplasia type 2.\n* Concurrent participation in another interventional pharmacological clinical trial.\n* Any condition that, in the investigator's judgment, may compromise participant safety, interfere with protocol compliance, or make participation inappropriate.","FEMALE","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","SHAPE-ENDO is a single-center, open-label, pilot randomized clinical trial conducted at Hospital Universitari de Bellvitge in Barcelona, Spain.\n\nThe study will evaluate the feasibility, safety, and acceptability of comparing two treatment strategies in women with atypical endometrial hyperplasia\u002Fendometrial intraepithelial neoplasia or low-risk endometrioid endometrial cancer and grade III obesity, defined as BMI ≥40 kg\u002Fm².\n\nEligible participants will be randomized in a 1:1 ratio to one of two arms. The control arm will undergo standard immediate surgery according to the institutional clinical protocol. The experimental arm will receive the SHAPE-ENDO multimodal pre-surgical optimization strategy before surgery.\n\nThe SHAPE-ENDO strategy includes metabolic treatment with semaglutide\u002FWegovy®, local hormonal therapy with a levonorgestrel-releasing intrauterine device\u002FMirena® with or without oral medroxyprogesterone acetate\u002FProgevera®, a structured nutritional program, adapted physical exercise, and scheduled oncologic surveillance with clinical evaluation, imaging, and endometrial biopsy with or without hysteroscopy.\n\nThe experimental strategy will initially last 28 weeks. In participants with clinical, metabolic, or anthropometric benefit, adequate tolerance, and no evidence of tumor progression, the strategy may be extended up to 54 weeks before surgery.\n\nThe primary objective is to evaluate the feasibility, safety, and acceptability of the randomized trial design. Primary feasibility outcomes include recruitment rate, acceptance of randomization, retention, adherence to the assigned intervention, completion of the SHAPE-ENDO strategy, progression during the optimization period, and the proportion of participants in the experimental arm who reach surgery without tumor progression.\n\nSecondary outcomes include perioperative morbidity, histological response in the experimental arm, metabolic and anthropometric changes, quality of life, treatment adherence, safety and tolerability, and exploratory long-term oncologic outcomes including overall survival, recurrence-free survival, and cancer-specific survival.",[27,28,29,30,31,32,33,34,35],"Endometrial Cancer","Endometrial Cancer Stage I","Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I","Atypical Endometrial Hyperplasia","Endometrial Intraepithelial Neoplasia","Obesity & Overweight","BMI>40","Obesity","Obesity Grade III",[37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55],"Semaglutide","GLP-1 receptor agonist","levonorgestrel IUD","hormonal therapy","prehabilitation","minimally invasive surgery","robotic surgery","metabolic optimization","endometrial hyperplasia","weight loss intervention","endometrial cancer","endometrial carcinoma","early stage","obesity","cancer","real-world evidence","prospective","ClinicalTrial","wegovy","NOT_YET_RECRUITING","2026-06-06",{"date":59,"type":60},"2026-06-10","ACTUAL",{"date":62,"type":21},"2027-01",{"date":64,"type":21},"2035-01",{"name":66,"class":67},"Hospital Universitari de Bellvitge","OTHER",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100523988","phase-2-progesterone-therapeutic-regimen-plus-statins-in-young-women-with-early-endometrial-carcinoma-and-atypical-endometrial-hyperplasia-100523988","NCT06102863","Progesterone Therapeutic Regimen Plus Statins in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia","Inclusion Criteria:\n\n* The pathological types are consistent with:\n\n  1. Atypical endometrial hyperplasia;\n  2. Patients with highly differentiated endometrioid adenocarcinoma, stage IA, and pelvic and abdominal MRI before treatment excluded deep muscle infiltration, cervical involvement, and extrauterine metastasis;\n  3. There is a strong need to preserve reproductive function; Age ≤45 years old;\n  4. Progesterone resistant patients predicted by the progesterone sensitivity prediction model (NCT05647109) established by our team in the previous study of endometrial cancer were prospectively randomized; The predicted progesterone sensitive patients were prospectively observed;\n  5. Informed consent and signed informed consent;\n  6. have follow-up conditions and are willing to continue to follow the visitors in the hospital;\n  7. Patients with normal\u002Fabnormal blood lipids who have not taken any lipid-lowering drugs;\n  8. A. Newly treated patients: did not use any nursery therapy drugs (progesterone, GNRH-a); B. 1 course of treatment (12 weeks) the lesions persisted; C. Partial remission for 2 courses of treatment (24 weeks);\n\nExclusion Criteria:\n\n* (1) Patients with severe internal diseases and severe impairment of liver and kidney function;\n\n  (2) Disease progression, extrauterine metastasis (cervical invasion or distant metastasis such as pelvic cavity) during treatment;\n\n  (3) People with therapeutic drug allergies and contraindications;\n\n  (4) Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; Patients with breast cancer or other hormone-dependent tumors that cannot use progesterone;\n\n  (5) Patients with deep vein thrombosis, stroke and myocardial infarction during treatment;\n\n  (6) Alcoholics (\\> 20g\u002F day);\n\n  (7) Smokers (\\> 15 cigarettes\u002Fday)","17 Years","45 Years",{"count":77,"type":21},38,[79],"PHASE2","To explore the treatment efficacy of Progesterone Therapeutic Regimen Plus Statins in patients with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC) for conservative treatment.",[29],"RECRUITING","2025-04-25",{"date":85,"type":60},"2025-04-29",{"date":87,"type":60},"2023-04-01",{"date":89,"type":21},"2025-09-01",{"name":91,"class":67},"Peking University People's Hospital",1]