[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atypical-endometrial-hyperplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atypical-endometrial-hyperplasia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,68,96,123,157,179,202,217,238,265,285],{"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":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100463576","phase-2-weight-management-plus-lng-iusmegestrol-acetate-in-endometrial-atypical-hyperplasia-100463576","NCT05316493","Weight Management Plus LNG-IUS\u002FMegestrol Acetate in Endometrial Atypical Hyperplasia","Weight Management Plus Levonorgestrel Intrauterine System or Megestrol Acetate in Endometrial Atypical Hyperplasia: Multiple Single-arm, Prospective and Open-label Clinical Study","Inclusion Criteria:\n\n1.18 years≤age≤45years 2.BMI (body mass index) ≥24kg\u002Fm2 3.Consent informed and signed 4.Pathologically confirmed as endometrial atypical hyperplasia. Patients with endometrial specimens obtained by endometrial biopsy, diagnostic curettage or hysteroscopy and diagnosed histologically as endometrial atypical hyperplasia. If specimens are from other hospitals, they must be counseled or reconfirmed by the Department of Pathology of the Obstetrics and Gynecology Hospital of Fudan University.\n\n5.Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements.\n\n6.Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time.\n\nExclusion Criteria:\n\n1. Combined with severe medical disease or liver or kidney dysfunction: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level elevates to 3 times or more of the upper limit of normal, kidney dysfunction (creatinine clearance \\\u003C 30 mL\u002Fmin)\n2. Patients are diagnosed with other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that cannot be used with progesterone.\n3. Those who have received high doses of high potency progestin or oral contraceptives within the last 3 months (or those on maintenance medication).\n4. Those who require hysterectomy or other methods other than conservative treatment.\n5. Known or suspected pregnancy.\n6. Those who has contraindications to use progestin.\n7. Deep vein thrombosis, stroke, myocardial infarction.\n8. Severe joint lesions that prevent walking or movement.\n9. untreated or recurrent pelvic inflammatory disease (PID)\n10. an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);\n11. Cervical dysplasia\n12. Congenital or acquired uterine abnormalities, including uterine fibroid tumors or conditions that affect the shape of the uterus\n13. allergic to the LNG-IUS components\n14. uterine cavity is too large (average uterine diameter is over 7 cm) or have a history of LNG-IUS falling out.\n\nNotes: the last 6 criteria are only applied for patients with LNG-IUS.","45 Years",{"count":77,"type":21},172,[79,80],"PHASE2","PHASE3","To investigate the efficacy of weight management plus levonorgestrel intrauterine system (LNG-IUS) or megestrol acetate (MA) in obese patients with endometrial atypical hyperplasia (EAH) asking for conservative therapy.",[30,83,84],"Fertility Issues","Overweight and Obesity","RECRUITING","2026-06-03",{"date":88,"type":60},"2026-06-04",{"date":90,"type":60},"2022-06-13",{"date":92,"type":21},"2027-02-28",{"name":94,"class":67},"Xiaojun Chen",1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100443232","leveraging-methylated-dna-markers-mdms-in-the-detection-of-endometrial-cancer-ovarian-cancer-and-cervical-cancer-100443232","NCT05051722","Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer","Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer: a Phase II Clinical Study","ECHO","Inclusion Criteria for Cohort 1:\n\nPatients will be ≥45 years of age and meet one of the following criteria:\n\n* Abnormal uterine bleeding\n* Postmenopausal bleeding\n\nOR\n\nPatients ages 18 - 44 years of age and meet these criteria\n\n* Abnormal uterine bleeding\n* One risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use)\n\nExclusion Criteria for Cohort 1:\n\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Any prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Current biopsy-proven cervical, vaginal, or vulvar cancer or lower genital tract dysplasia\n* Current biopsy-proven endometrial cancer or endometrial hyperplasia\n* Current biopsy-proven benign endometrial polyp\n* Endometrial biopsy\u002Fsampling within the preceding 1 month showing benign endometrium\n\nInclusion Criteria for Cohort 2:\n\nPatients will be ≥18 years of age and meet at least one of the following criteria:\n\n* Presence of biopsy-proven EC (any histology, including uterine carcinosarcoma) and surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\\&C, hysteroscopic resection\n* Biopsy showing AEH or EIN with surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\\&C, hysteroscopic resection, etc)\n\nExclusion Criteria for Cohort 2:\n\n* Undergoing surgical procedure for recurrent or metastatic EC\n* Received preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Prior or current biopsy-proven cervical cancer\n* Presence of concomitant biopsy-proven cervical dysplasia\n* Any prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Prior intervention or surgery with intent to completely remove the target pathology\n\nInclusion Criteria for Cohort 3:\n\nPatients will be ≥18 years of age, have a cervix and meet at least one of the following criteria:\n\n* History of current abnormal cervical\u002Fendocervical Pap test for which the patient is presenting for colposcopy\n* Cervical mass identified on physical exam and patient referred for cervical biopsy, even if colposcopy not recommended or indicated\n* Planned clinically indicated surgical excisional biopsy or removal of the cervix (cold knife cone, LEEP, hysterectomy) for abnormal Pap test, cervical dysplasia, cervical mass, or biopsy-proven invasive cervical cancer (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or less common primary cervical carcinomas all eligible)\n\nExclusion Criteria for Cohort 3:\n\n* History of pelvic or vaginal radiotherapy\n* Prior total hysterectomy (cervix removed) for any indication\n* Current known pregnancy diagnosis\n* Cervical mass biopsy-proven to be EC or a cancer metastatic from a non-cervical origin\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Patients presenting for colposcopy as part of lower genital tract dysplasia or cancer surveillance after prior curative intent treatment and no current Pap abnormality or cervical mass\n* Prior intervention or surgery with intent to completely remove the target pathology for the current lesion \u002F diagnosis during the current episode\n\nInclusion Criteria for Cohort 4:\n\nPatients will be ≥45 years of age and should meet at least one of the following criteria:\n\n* Undergoing hysterectomy with biopsy-proven or clinically presumed (based on imaging and\u002For clinical symptoms) benign gynecologic or uterine pathology of fibroids, endometriosis, adenomyosis, or benign endometrial polyps.\n* Undergoing any gynecologic surgery in which a benign pathologic tissue diagnosis of fibroids, endometriosis, adenomyosis, or benign endometrial polyp is anticipated to be confirmed.\n\nExclusion Criteria for Cohort 4:\n\n* Endometrial biopsy or office hysteroscopy within 2 weeks preceding the planned gynecologic surgery procedure for fibroids, endometriosis, benign endometrial polyps, or adenomyosis\n* Any surgery within the past 3 months\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Prior or current biopsy-proven gynecologic cancer\n* Current biopsy-proven AEH\u002FEIN, cervical, vaginal, or vulvar dysplasia\n* Prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Undergoing hysterectomy for prolapse without a coexisting known or presumed benign uterine pathologic diagnosis of fibroids, endometriosis, benign endometrial polyps, or adenomyosis\n* Prior intervention or surgery with intent to completely remove the target pathology for the current lesion \u002F diagnosis during the current episode\n\nInclusion Criteria for Cohort 5:\n\nPatients with a uterus will be ≥45 years of age and should meet the following criteria:\n\n* Presenting for GYN wellness exam, ± Pap test\n* No change in medical conditions, new diagnoses, or new medications within the past 6 months\n\nExclusion Criteria for Cohort 5:\n\n* Pap test or cervical biopsy within the past 1 month\n* Endometrial biopsy or office hysteroscopy within the past 1 month\n* Any surgery within the past 3 months\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Prior or current biopsy-proven gynecologic cancer\n* Current biopsy-proven AEH\u002FEIN, cervical, vaginal, or vulvar dysplasia\n* Prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Criteria met for inclusion in any of the other study cohorts\n\nInclusion Criteria for Cohort 6:\n\nPatients ≥50 years of age and:\n\n* Postmenopausal\n* At least 1 intact ovary\n* Diagnosis of an adnexal mass or a clinical suspicion of early-stage ovarian cancer (including fallopian tube cancer)\n* Planned surgery for the adnexal mass\n* For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\\* (without prior tubal ligation\u002Focclusion)\n\nExclusion criteria for Cohort 6:\n\n* Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn)\n* Chemotherapy for cancer treatment within the past 5 years prior to collection\n* Clinically suspected advanced stage ovarian cancer (Stage III or IV) on presentation, if known prior to specimen collection\n* Surgical candidates for recurrent ovarian cancer\n* History of pelvic or vaginal radiation therapy\n* Known current synchronous endometrial cancer or hyperplasia\n* Known current cervical, vaginal, or vulvar dysplasia\n\nInclusion criteria for Cohort 7:\n\nWomen will be ≥18 years of age and meet the following criteria:\n\n* Presence of clinically probable ovarian, fallopian tube, or primary peritoneal cancer (all under the umbrella of OC) based on clinical findings of any\u002Fall of the following: imaging showing adnexal and\u002For abdominal masses consistent with probable ovarian cancer, omental caking, elevated CA125, ascites, imaging-guided biopsy consistent with OC pathology\n* Newly diagnosed with ovarian, fallopian tube or primary peritoneal cancer without neoadjuvant therapy\n* At least one intact ovary\n* For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\\* (without prior tubal ligation\u002Focclusion)\n\nExclusion criteria for Cohort 7:\n\n* Patients with recurrent OC\n* Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years\n* Chemotherapy for cancer treatment within the past 5 years prior to collection\n* History of pelvic or vaginal radiation therapy\n* Known current synchronous endometrial cancer or hyperplasia\n* Known current cervical, vaginal, or vulvar dysplasia\n* Current known pregnancy diagnosis",{"count":105,"type":21},3110,"OBSERVATIONAL","The overarching objective of this project is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and\u002For plasma.\n\nThis proposal defines Phase II MDM-based cancer detection studies in endometrial cancer (EC) and endometrial hyperplasia with atypia (AEH) in vaginal fluid and 2) ovarian cancer (OC) in plasma and vaginal fluid. Additionally, it defines necessary Phase I MDM-based cancer detection and exploratory aims to test novel cervical cancer (CC) MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.er detection and exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.",[27,109,30,110,111,112],"Cervical Cancer","Cervical Dysplasia","Adnexal Mass","Ovarian Cancer","2026-04-16",{"date":115,"type":60},"2026-04-17",{"date":117,"type":60},"2021-08-03",{"date":119,"type":21},"2027-06-30",{"name":121,"class":67},"Mayo Clinic",24,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":133,"conditions":134,"keywords":137,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":95},"100634822","endometrial-cancer-vaginal-fluid-specimen-collection-study-100634822","NCT07544680","Endometrial Cancer Vaginal Fluid Specimen Collection Study","Endometrial Cancer Vaginal Fluid Specimen Collection Study: \"ENVISION\"","ENVISION","Inclusion Criteria\n\nCohort 1 Participants:\n\n* Age ≥ 45 years, OR age ≥ 18 years with at least one risk factor\n* Diagnosed with abnormal uterine bleeding (AUB)\n* Planning standard-of-care endometrial tissue sampling to assess for endometrial cancer (EC) or atypical endometrial hyperplasia\u002Fendometrial intraepithelial neoplasia (AEH\u002FEIN)\n\nCohort 2 Participants:\n\n* Age ≥ 18 years\n* Newly diagnosed, biopsy-confirmed EC or AEH\u002FEIN\n* Planning initial management for their endometrial pathology\n\nExclusion Criteria\n\n* Prior partial or complete hysterectomy\n* Current pregnancy\n* Prior pelvic or vaginal radiotherapy\n* Chemotherapy within past 5 years (except tamoxifen)\n* Any condition judged by the Investigator to preclude participation\n\nAdditional for Cohort 1:\n\n* Cancer diagnosis within past 5 years (except non-gynecologic skin cancer)\n* Current biopsy-proven cervical, vaginal, or vulvar cancer, or lower genital tract dysplasia\n* Current biopsy-proven endometrial cancer, hyperplasia, or benign polyp\n* Benign endometrial biopsy within last month\n\nAdditional for Cohort 2:\n\n* Cancer diagnosis other than EC within past 5 years (except non-gynecologic skin cancer)\n* Prior cervical cancer or biopsy-proven cervical dysplasia\n* Surgery for recurrent EC\n* Preoperative neoadjuvant chemotherapy or radiotherapy for current EC\n* Prior treatment or surgery to remove target pathology during current episode",{"count":132,"type":21},4200,"This is a multicenter, prospective, specimen collection study for development and evaluation of tests used to detect endometrial cancer, other cancers, or their causes.",[135,27,30,136,31],"Abnormal Uterine Bleeding (AUB)","Endometrial Hyperplasia With Atypia",[135,138,139,140,141,142,143,144,145,146],"Endometrial Cancer (EC)","Atypical Endometrial Hyperplasia (AEH)","Endometrial Hyperplasia with Atypia","Endometrial Intraepithelial Neoplasia (EIN)","Precancerous Conditions","Post-Menopausal Bleeding","Specimen Collection","Sample Collection","in vitro diagnostic (IVD) devices","2026-04-15",{"date":149,"type":60},"2026-04-22",{"date":151,"type":60},"2026-03-10",{"date":153,"type":21},"2028-04-24",{"name":155,"class":156},"Exact Sciences Corporation","INDUSTRY",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":95},"100621985","phase-2-intrauterine-injection-of-type-iii-collage-in-fst-of-ecaeh-100621985","NCT07377734","Intrauterine Injection of Type III Collage in FST of EC\u002FAEH","A Multicenter, Randomized, Open-Label, Controlled Clinical Trial of Intrauterine Injection of Recombinant Humanized Type III Collage in the Fertility-Sparing Treatment of Endometrial Cancer or Atypical Hyperplasia","2026ColECFerSp","Inclusion Criteria:\n\n1. Pathological diagnosis of endometrioid adenocarcinoma (G1 or G2) or atypical endometrial hyperplasia.\n2. For patients with endometrial cancer, magnetic resonance imaging (MRI) or ultrasound must confirm that the lesion is confined to the endometrium or invades less than 1\u002F2 of the myometrium (i.e., FIGO 2009 Stage IA).\n3. Age ≤ 45 years.\n4. Desire to preserve fertility and signed informed consent.\n5. No serious medical comorbidities (e.g., severe liver or renal dysfunction).\n6. No contraindications to progestin therapy or pregnancy.\n7. No evidence of distant metastasis on imaging.\n\nExclusion Criteria:\n\n1. Tumor invasion \\> 1\u002F2 of the myometrium, or FIGO (2009) Stage IB and above.\n2. Tumor differentiation grade G3 or non-endometrioid adenocarcinoma.\n3. Coexistence of other malignant tumors.\n4. Contraindications to conservative treatment or use of the study drugs.\n5. Known allergy to recombinant protein components.\n6. Acute genital tract inflammation or untreated abnormal vaginal discharge within 2 weeks prior to enrollment.\n7. Previous treatment with high-potency progestin for more than 1 month.",{"count":166,"type":21},30,[79],"The goal of this clinical trial is to learn if intrauterine injection of \"Recombinant Humanized Type III Collagen Lyophilized Fibers\" works to treat endometrial cancer or atypical hyperplasia in patients seeking fertility-preserving treatment. It will also learn about the safety of this intervention.The main questions it aims to answer are:\n\n1. Does the combination of recombinant humanized type III collagen and progestin significantly increase the tumor remission rate at 6 months compared to progestin alone?\n2. What medical problems do participants have when receiving this treatment (e.g., allergic reactions, abnormal inflammatory markers, or histocompatibility issues)? Researchers will compare \"recombinant humanized type III collagen plus progestin (experimental group)\" to \"high-dose progestin alone (control group)\" to see if the combination therapy is more effective for fertility preservation.\n\nParticipants will:\n\n1. Take high-dose progestin (such as Medroxyprogesterone Acetate or Megestrol Acetate) orally every day.\n2. If assigned to the experimental group, receive one intrauterine submucosal injection of collagen via hysteroscopy at months 0, 1, and 2, for a total of 3 injections.\n3. Visit the clinic once every 3 months for treatment evaluation and follow-up, which includes hysteroscopic endometrial biopsy, imaging (such as transvaginal ultrasound), and safety tests for relevant biochemical indicators.",[30,27],"2026-03-24",{"date":172,"type":60},"2026-03-30",{"date":174,"type":60},"2026-01-30",{"date":176,"type":21},"2029-12-30",{"name":178,"class":67},"Wang Jianliu",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},"100545224","phase-2-gnrha--letrozole-in-obese-progestin-insensitive-endometrial-cancer-patients-100545224","NCT06379113","GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients","Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Obese Progestin-insensitive Early-stage Endometrial Cancer Patients With Conservative Treatment","Inclusion Criteria:\n\n* Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove well-differentiated EEC G1 without myometrial invasion\n* BMI≥30kg\u002Fm2\n* No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound\n* Using progestin, any of the following therapy, as first-line treatment:\n\n  1. Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not\n  2. Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not\n  3. LNG-IUS inserted\n* Progestin-insensitive:\n\n  1. remained with stable disease after 7 months of progestin use\n  2. did not achieve CR after 10 months of progestin use\n* Have a desire for remaining reproductive function or uterus\n* Good compliance with adjunctive treatment and follow-up\n\nExclusion Criteria:\n\n* Combined with severe medical disease or severely impaired liver and kidney function\n* Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis\n* Patients with other types of endometrial cancer or other malignant tumors of the reproductive system\n* Patients with breast cancer or other hormone- dependent tumors or diseases that cannot be used with GnRHa or Letrozole\n* Strong request for uterine removal or other conservative treatment\n* Known or suspected pregnancy\n* Acute severe disease such as stroke or heart infarction or a history of thrombosis disease\n* Smoker(\\>15 cigarettes a day)",{"count":187,"type":21},29,[79,80],"To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC patients.",[191,30,192,34],"Endometrial Neoplasms","Progesterone Resistance","2025-08-06",{"date":195,"type":60},"2025-08-11",{"date":197,"type":60},"2022-07-13",{"date":199,"type":21},"2027-03-30",{"name":94,"class":67},2,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":215,"leadSponsor":216,"locationsCount":201},"100463610","phase-2-gnrha--letrozole-in-non-obese-progestin-insensitive-endometrial-cancer-and-atypical-hyperplasia-patients-100463610","NCT05316935","GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients","Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Non-obese Progestin-insensitive Early-stage Endometrial Cancer and Atypical Hyperplasia Patients With Conservative Treatment","Inclusion Criteria:\n\n* Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove EAH or well-differentiated EEC G1 without myometrial invasion\n* BMI\\\u003C30kg\u002Fm2\n* No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound\n* Using progestin, any of the following therapy, as first-line treatment:\n\n  1. Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not\n  2. Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not\n  3. LNG-IUS inserted\n* Progestin-insensitive:\n\n  1. remained with stable disease after 7 months of progestin use\n  2. did not achieve CR after 10 months of progestin use\n* Have a desire for remaining reproductive function or uterus\n* Good compliance with adjunctive treatment and follow-up\n\nExclusion Criteria:\n\n* Combined with severe medical disease or severely impaired liver and kidney function\n* Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis\n* Patients with other types of endometrial cancer or other malignant tumors of the reproductive system\n* Patients with breast cancer or other hormone- dependent tumors or diseases that cannot be used with Diane-35, GnRHa, Letrozole or MET\n* Strong request for uterine removal or other conservative treatment\n* Known or suspected pregnancy\n* Acute severe disease such as stroke or heart infarction or a history of thrombosis disease\n* Smoker(\\>15 cigarettes a day)",{"count":20,"type":21},[79,80],"To investigate the efficacy of GnRHa plus letrozole vs Diane-35 plus metformin in non-obese progestin-insensitive early-stage endometrial cancer (EEC) and atypical hyperplasia(EAH) patients asking for conservative treatment.",[191,30,192],{"date":195,"type":60},{"date":197,"type":60},{"date":199,"type":21},{"name":94,"class":67},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":225,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":235,"leadSponsor":236,"locationsCount":95},"100595114","ultrasound-and-histology-in-aeh-and-early-eec-treated-conservatively-100595114","NCT07028242","Ultrasound and Histology in AEH and Early EEC Treated Conservatively","Ultrasound and Histological Features of Patients With Atypical Endometrial Hyperplasia and Early Endometrioid Endometrial Carcinoma Submitted to Fertility Sparing Treatment.","ULTRA-SAFE","Inclusion Criteria:\n\nWomen aged 18-45 years.\n\nHistologically confirmed atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-2.\n\nCandidates for fertility-sparing treatment (hysteroscopic resection and\u002For progestin therapy).\n\nNo prior history of invasive endometrial carcinoma.\n\nAdequate endometrial visualization via transvaginal ultrasound (TVUS) and\u002For MRI.\n\nSigned informed consent for study participation.\n\nExclusion Criteria:\n\nWomen under 18 or over 45 years.\n\nPresence of myometrial invasion on MRI or histological analysis.\n\nHistological diagnosis of serous carcinoma, clear cell carcinoma, or undifferentiated carcinoma.\n\nHistory of previous hysterectomy or non-conservative surgical treatment.\n\nContraindications to hormonal therapy (e.g., thromboembolic disease, hormone-dependent malignancies).\n\nPregnancy at the time of enrollment.\n\nLack of adequate imaging for ultrasound-based assessment.",{"count":226,"type":21},50,"Ultra-S.A.F.E. is a multicenter, ambispective observational study investigating the ultrasound and histological characteristics of patients with atypical endometrial hyperplasia (AEH) or endometrioid endometrial carcinoma (EEC) G1-2 undergoing fertility-sparing treatment (FST). The study aims to describe pre-treatment ultrasound features, evaluate endometrial modifications during treatment, and assess histological and reproductive outcomes. It includes a prospective cohort (new patients recruited at three gynecologic oncology centers) and a retrospective cohort (patients treated conservatively since January 2023). Approximately 50 patients will be enrolled over 24 months, with clinical, ultrasound, and histological data collected. The ultimate goal is to enhance the diagnostic and monitoring role of transvaginal ultrasound (TVUS) in conservative treatment for fertility preservation.",[229,30,230],"Fertility-Sparing Treatment (FST)","Early Endometrial Cancer (EEC)","2025-06-11",{"date":233,"type":60},"2025-06-19",{"date":231,"type":21},{"date":119,"type":21},{"name":237,"class":67},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":245,"maxAge":75,"enrollmentInfo":246,"targetDuration":248,"studyType":106,"phases":4,"briefSummary":249,"conditions":250,"keywords":252,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":95},"100488976","patient-derived-tumor-like-cell-clusters-predict-progesterone-sensitivity-in-patients-with-early-endometrial-cancer-100488976","NCT05647109","Patient-derived Tumor-like Cell Clusters Predict Progesterone Sensitivity in Patients With Early Endometrial Cancer","Department of Obstetrics & Gynecology ，Peking University People's Hospital","Inclusion Criteria:\n\n* Have a confirmed pathological diagnosis based upon hysteroscopy: atypical endometrial hyperplasia or histologically prove well-differentiated EEC G1 without myometrial invasion\n* No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound\n* Have a desire for remaining reproductive function or uterus\n* Good compliance with adjunctive treatment and follow-up\n\nExclusion Criteria:\n\n* Acute liver disease or liver tumor (benign or malignant) or renal dysfunction\n* Pregnancy or potential pregnancy\n* Confirmed diagnosis of any cancer in reproductive system\n* Acute severe disease such as stroke or heart infarction or a history of thrombosis disease\n* Hypersensitivity or contradiction for using MPA or MA\n* With other factors of reproductive dysfunction;\n* Strong request for uterine removal or other conservative treatment","17 Years",{"count":247,"type":21},244,"1 Year","To construct a prediction model of progesterone sensitivity in patients with endometrial cancer treated with fertility preservation",[251,30],"Endometrial Carcinoma Stage I",[253,254,255],"Progesterone","Patient-derived tumor-like cell clusters","Endometrial Carcinoma","2025-05-02",{"date":258,"type":60},"2025-05-04",{"date":260,"type":60},"2021-09-01",{"date":262,"type":21},"2025-10-31",{"name":264,"class":67},"Peking University People's Hospital",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":245,"maxAge":75,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":274,"briefSummary":275,"conditions":276,"keywords":277,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":284,"locationsCount":95},"100491181","phase-2-medroxyprogesterone-acetate-plus-atorvastatin-in-young-women-with-early-endometrial-carcinoma-and-atypical-endometrial-hyperplasia-100491181","NCT05675787","Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia","Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma","Inclusion Criteria:\n\n* Have a confirmed pathological diagnosis based upon hysteroscopy: histologically prove AEH or well-differentiated EEC G1 without myometrial invasion: 1. Untreated patients; 2. Patients with persistent lesions after one course (12 weeks) of progesterone therapy; 3. Patients who did not achieve complete remission after 2 courses (24 weeks) of progesterone therapy;\n* No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound\n* Have a desire for remaining reproductive function or uterus\n* Good compliance with adjunctive treatment and follow-up\n\nExclusion Criteria:\n\n* Hypersensitivity or contradiction for using MPA or atorvastatin\n* Pregnancy or potential pregnancy\n* Confirmed diagnosis of any cancer in reproductive system\n* Already diagnosed with hyperlipidemia and using lipid-lowering drugs\n* Acute liver disease or liver tumor (benign or malignant) or renal dysfunction\n* Acute severe disease such as stroke or heart infarction or a history of thrombosis disease\n* With other factors of reproductive dysfunction;\n* Strong request for uterine removal or other conservative treatment\n* Smoker (\\>15 cigarettes a day)\n* Drinker (\\>20 grams a day)",{"count":273,"type":21},82,[79],"To explore the treatment efficacy of medroxyprogesterone acetate plus atorvastatin in patients with atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EEC) for conservative treatment.",[30,251],[255,30],"2024-07-09",{"date":280,"type":60},"2024-07-11",{"date":282,"type":60},"2023-01-06",{"date":262,"type":21},{"name":264,"class":67},{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":292,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":95},"100321314","phase-2-value-of-lng-ius-as-fertility-preserving-treatment-of-eah-and-ec-100321314","NCT03463252","Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC","Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma","For Patients With Endometrial Cancer：\n\nInclusion Criteria:\n\n* ≤40 years of age:\n* Having a strong desire for fertility preservation;\n* Histological diagnosis is confirmed as well-differentiated (grade 1) endometrioid adenocarcinoma by the designated gynecological pathologists, and the progesterone receptors (PgRs) is positive in immunohistochemistry;\n* Disease limited to the endometrium (stage 1A) on MRI;\n* Serum CA125\u002F199 level is within normal limit (Laparoscopic exploration to rule out ovarian tumor or another metastasis if necessary);\n* Patients should have undergone counseling to learn fertility-preserving treatment is not standard of care for the treatment of EC, volunteered to participate in this study, signed the informed consent form, and agreed to participated in clinical follow-up.\n\nExclusion Criteria:\n\n* Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs;\n* Patients have lynch syndrome (LS);\n* Patients have contraindications for pregnancy;\n* Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute liver or kidney diseases, acute or subacute genital tract infections and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible);\n* Patients refuse to participate in clinical follow-up or sign the informed consent form.\n\nFor Patients With Endometrial atypical hyperplasia：\n\nInclusion Criteria:\n\n* ≤ 40 years of age\n* Having a strong desire for fertility preservation\n* Histological diagnosis is confirmed as atypical endometrial hyperplasia (EAH) by the designated gynecological pathologists\n* Having volunteered to participate in this study, signed the informed consent form, and agreed to participate in clinical follow-up\n\nExclusion Criteria:\n\n* Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs\n* Patients have contraindications for pregnancy\n* Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute or subacute genital tract infections, and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible)\n* Patients refuse to participate in clinical follow-up or sign the informed consent form.","40 Years",{"count":294,"type":21},224,[79,80],"Primary end points:\n\nThis clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing Intrauterine System (LNG-IUS, Mirena®) in the fertility-sparing treatment of atypical endometrial hyperplasia and early endometrial carcinoma, including pathology response and pregnancy outcome.\n\nSecond end points:\n\nTo analyze the appearances of side-effects.",[27,30],"2021-09-03",{"date":300,"type":60},"2021-09-13",{"date":302,"type":60},"2018-04-01",{"date":304,"type":21},"2030-12-30",{"name":306,"class":67},"West China Second University Hospital"]