[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628517":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":92,"centralContacts":98,"locations":103,"responsibleParty":105,"collaborators":108,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":103,"enrollmentInfo":121,"targetDuration":103,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":138,"overallStatus":157,"whyStopped":103,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":103},{"fullName":5,"class":6},"Hospital Universitari de Bellvitge","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A - Standard Immediate Surgery","ACTIVE_COMPARATOR","Participants randomized to the control arm will undergo standard immediate surgical treatment according to the institutional protocol of Hospital Universitari de Bellvitge. Surgery will usually include hysterectomy with bilateral salpingo-oophorectomy, sentinel lymph node assessment when indicated and feasible, and minimally invasive or robotic approach whenever technically possible according to clinical judgment.\n\nIntervention: Procedure\u002FSurgery - Standard Immediate Surgery Standard surgical management according to institutional practice for atypical endometrial hyperplasia\u002Fendometrial intraepithelial neoplasia or early-stage low-risk endometrioid endometrial cancer. Perioperative outcomes, surgical approach, conversion to laparotomy, estimated blood loss, operative time, hospital stay, transfusion, sentinel lymph node detection, intraoperative complications, and 30-day postoperative complications graded according to Clavien-Dindo will be recorded.",[13],"Procedure: Standar upfront Surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B - Experimental: SHAPE-ENDO Multimodal Strategy Before Surgery","EXPERIMENTAL","Participants randomized to the experimental arm will receive the SHAPE-ENDO multimodal pre-surgical optimization strategy before surgery. The strategy includes semaglutide\u002FWegovy®, levonorgestrel-releasing intrauterine device\u002FMirena® with or without oral medroxyprogesterone acetate\u002FProgevera®, structured nutritional intervention, adapted physical exercise, and scheduled oncologic surveillance. The strategy will last 28 weeks initially and may be extended up to 54 weeks if there is clinical, metabolic, or anthropometric benefit, adequate tolerance, and no tumor progression.\n\nIntervention: Drug - Semaglutide \u002F Wegovy® Weekly subcutaneous semaglutide administered according to approved labeling, clinical indication, tolerance, and endocrinology assessment, with standard dose escalation up to the tolerated therapeutic dose. Dose, adherence, tolerability, adverse events, and reasons for dose modification or discontinuation will be recorded.\n\nIntervention: Device - Levonorgestrel-Releasing I",[19,20,21,22,23,24,25],"Drug: GLP-1 Receptor Agonist","Device: Levonorgestrel IUD (Lng-IUD)","Drug: Oral Progestins","Behavioral: Dietetic-Nutritional intervention","Behavioral: Structured Exercise and Prehabilitation Program","Procedure: Endometrial Biopsy With or Without Hysteroscopy","Procedure: Radiologic Surveillance (MRI and Transvaginal Ultrasound)",[27,34,41,49,58,66,75,83],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","GLP-1 Receptor Agonist","Weekly subcutaneous semaglutide\u002FGLP-1 receptor agonist therapy administered according to approved labeling, clinical indication, patient tolerance, and endocrinology assessment, with standard dose escalation up to the tolerated therapeutic dose. The intervention is used for weight loss and metabolic optimization in participants with severe obesity. Dose, adherence, tolerability, and reasons for dose modification or discontinuation will be recorded prospectively.",[15],[33],"Semaglutide",{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DEVICE","Levonorgestrel IUD (Lng-IUD)","Local hormonal therapy using a 52-mg levonorgestrel-releasing intrauterine system placed at baseline or within 14 days after baseline, with ultrasound confirmation of correct placement. The LNG-IUD is used within the protocolized SHAPE-ENDO strategy according to clinical indication, approved labeling, current guidelines, and physician judgment, for local disease control in atypical endometrial hyperplasia\u002Fendometrial intraepithelial neoplasia or early-stage, low-risk endometrioid endometrial cancer. Tolerability, continuation, adverse events, and local histological response will be recorded prospectively.",[15],[40],"LNG-IUD",{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Oral Progestins","Systemic hormonal therapy prescribed according to clinical criteria to support local disease control in atypical endometrial hyperplasia or early-stage endometrioid carcinoma. Typical regimens include medroxyprogesterone acetate (400-600 mg\u002Fday) or megestrol acetate (160-320 mg\u002Fday). Therapy is initiated or escalated when indicated based on tumor burden or suboptimal response to LNG-IUD. Oral progestins may be used within the protocolized SHAPE-ENDO strategy according to clinical indication, approved labeling, current guidelines, and physician judgment. Use, dosing, tolerance, and outcomes will be recorded prospectively.",[15],[46,47,48],"Medroxyprogesterone acetate","Megestrol acetate","Progestin therapy",{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"BEHAVIORAL","Dietetic-Nutritional intervention","Personalized hypocaloric diet plan supervised by the clinical nutrition team as part of standard obesity and metabolic management. The program includes caloric restriction based on basal metabolic requirements, with the option of very low-calorie diets (VLCD) for 4-6 weeks in selected cases. Follow-up occurs at regular outpatient visits with recording of weight, BMI, waist circumference, and adherence. This intervention is part of routine clinical care and not assigned experimentally; outcomes are recorded prospectively.",[15],[55,56,57],"Hypocaloric diet program","Nutritional Counseling","Dietary Prehabiilitation",{"type":50,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Structured Exercise and Prehabilitation Program","A structured physical exercise program designed to improve functional capacity, aerobic tolerance, and surgical fitness. Program includes supervised or semi-supervised weekly sessions combining aerobic and strength training, typically 3 sessions per week for 30-45 minutes, adapted to baseline performance. The intervention is part of routine clinical care for patients with obesity undergoing surgical preparation and is not assigned experimentally. Data on adherence, tolerance, and functional outcomes are collected prospectively",[15],[63,64,65],"Exercise Prehabilitation","Supervised Physical Activity Program","Combined Aerobic and Strength Training",{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"PROCEDURE","Endometrial Biopsy With or Without Hysteroscopy","Scheduled histological surveillance performed at baseline and at follow-up intervals (typically 14 and 28-54 weeks) to assess local tumor status, including complete response, stability, or progression. Procedures include outpatient endometrial biopsy with optional hysteroscopy based on clinical indication. These evaluations form part of standard clinical care in patients managed conservatively for atypical endometrial hyperplasia or early-stage endometrioid carcinoma and are not assigned experimentally. Data are recorded prospectively to assess disease evolution and surgical eligibility.",[15],[72,73,74],"Histological Surveillance","Endometrial Sampling","Hysteroscopy",{"type":67,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"Radiologic Surveillance (MRI and Transvaginal Ultrasound)","Radiologic evaluation using pelvic MRI and transvaginal ultrasound performed as part of routine clinical care to assess uterine disease, myometrial invasion, adnexal status, and treatment response. Imaging is typically performed at baseline to confirm staging and during follow-up when clinically indicated. These imaging modalities are used per standard clinical guidelines and are not assigned experimentally; results are collected prospectively to evaluate disease stability and surgical planning.",[15],[80,81,82],"Pelvic MRI","Transvaginal Ultrasound","Imaging Surveillance",{"type":67,"name":84,"description":85,"armGroupLabels":86,"otherNames":87},"Standar upfront Surgery","Standard surgical treatment according to the institutional protocol of Hospital Universitari de Bellvitge for atypical endometrial hyperplasia\u002Fendometrial intraepithelial neoplasia or early-stage low-risk endometrioid endometrial cancer. Surgery will usually include hysterectomy with bilateral salpingo-oophorectomy, sentinel lymph node assessment when indicated and feasible, and a minimally invasive or robotic approach whenever technically possible according to clinical judgment. Surgical approach, operative time, estimated blood loss, conversion to laparotomy, transfusion, hospital stay, intraoperative complications, 30-day postoperative complications, readmission, and sentinel lymph node detection will be recorded.",[9],[88,89,90,91],"Standard Surgery","BSO","Hysterectomy","Upfront Surgery",[93,96],{"name":94,"affiliation":5,"role":95},"Jorge Garcia Fernandez","PRINCIPAL_INVESTIGATOR",{"name":97,"affiliation":5,"role":95},"Lola Marti",[99],{"name":100,"role":101,"phone":102,"phoneExt":103,"email":104},"Jorge Garcia Fernandez, MD","CONTACT","+34 622595644",null,"jorgarciafernan@gmail.com",{"type":95,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":103,"oldOrganization":103},"Jorge García Fernández","Specialist in Gynaecology and Obstetrics",[109],{"name":110,"class":6},"University of Barcelona","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":122,"type":123},80,"ESTIMATED","INTERVENTIONAL",[126],"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.",[129,130,131,132,133,134,135,136,137],"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",[33,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156],"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":160,"type":161},"2026-06-10","ACTUAL",{"date":163,"type":123},"2027-01",{"date":165,"type":123},"2035-01",{"name":5,"class":6}]