[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"endometrial-cancer-stage-i\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:endometrial-cancer-stage-i":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,68,94,123,150,179,203,230],{"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":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100384892","observational-study-of-women-with-endometrial-cancer-who-receive-the-standard-treatment-for-their-disease-100384892","NCT04291612","Observational Study of Women With Endometrial Cancer Who Receive the Standard Treatment for Their Disease","SEntinel Lymph Node Endometrial Cancer Trial: A Prospective Multicenter International Single-Arm Observational Trial (SELECT)","Screening Inclusion Criteria:\n\n* ECOG performance status 0-1 or KPS ≥ 70%\n* Age ≥ 18 years\n* Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation and curettage\n* No evidence of extrauterine disease, or suspicious pelvic lymph nodes, or distant metastases, or cervical invasion on pre-operative conventional imaging studies (Pelvic +\u002F- Abdomen CT or MRI or sonogram, or body PET scan) and physical examination (uterine confined by exam and imaging )\n* Suitable candidate for surgery\n* Planned surgical treatment including hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy\n* No history of second primary cancer (invasive or in situ) within the past 5 years, not including non-melanoma skin cancer\n* Approved and signed informed consent\n* No history of neoadjuvant chemotherapy or radiotherapy for endometrial cancer\n* No history of prior pelvic or abdominal radiotherapy\n\nScreening Exclusion Criteria:\n\n* Extrauterine disease, or gross lymph node involvement, or cervical invasion suspected on pre-operative imaging studies and physical examination (disease not uterine confined clinical stage \\> I)\n* Contraindication for SLN mapping\n* The planned treatment is not surgery, or the surgical treatment does not include hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy\n\nEligibility Inclusion Criteria\n\nPatients will be classified in the study cohort (part 2; n=182) according to surgical treatment received, final post hysterectomy and staging pathologic report, and planned adjuvant treatment. The inclusion criteria are specified below.\n\nStudy Cohort (n=182)\n\nA patient will be enrolled in the study cohort if all the following criteria are met:\n\n* At surgery, the patient must undergo:\n\n  * Hysterectomy\n  * Bilateral salpingo-oophorectomy, unless already performed (including allowing unilateral salpingo-oophorectomy if unilateral salpingo-oophorectomy already performed)\n  * Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for malignancy)\n* On the final pathologic report, the patient must have a diagnosis of:\n\n  * Stage I intermediate-risk endometrial endometrioid cancer (Grade 1 or Grade 2 with ≥ 50% myometrial invasion or Grade 3 with \\\u003C50% myometrial invasion, including non-invasive disease)\n  * Negative pelvic peritoneal cytology\n* Adjuvant treatment as recommended by the multidisciplinary team must be as follows:\n\n  * No adjuvant treatment, or\n  * Intravaginal radiation only\n\nEligibility Exclusion Criteria\n\n* There is intra-operative detection of extra-uterine disease or grossly involved lymph nodes\n* Presence of any positive pelvic nodes including micrometastasis and isolated tumor cells (ITC)\n* Hysterectomy is not performed\n* Bilateral salpingo-oophorectomy is not performed, unless already performed (unilateral salpingo-oophorectomy is allowed if unilateral salpingo-oophorectomy already performed)\n* Failed unilateral or bilateral SLN mapping\n* Patient undergoes a complete unilateral or bilateral pelvic lymphadenectomy\n* Patient undergoes a radical type C hysterectomy\n* Stage IA endometrioid cancer Grade1 or 2 and myometrial invasion \\\u003C50%\n* Stage IB Grade 3 endometrioid cancer\n* Non-endometrioid histology: Serous, clear cell, carcinosarcoma, undifferentiated, or de-differentiated histology noted on final hysterectomy pathology\n* Empty unilateral or bilateral sentinel lymph nodal packet(s)\n* Positive peritoneal cytology",{"count":76,"type":21},1715,"OBSERVATIONAL","This study is being done to find out how often endometrial cancer recurs after the standard treatment as well as how often the standard treatment results in a lymphedema.",[27,80,28],"Endometrioid Adenocarcinoma",[27,80,82,83],"20-067","Memorial Sloan Kettering Cancer Center","RECRUITING","2026-03-27",{"date":87,"type":60},"2026-04-01",{"date":89,"type":60},"2020-02-26",{"date":91,"type":21},"2027-02-26",{"name":83,"class":67},19,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":93},"100368161","phase-3-sentinel-node-biopsy-in-endometrial-cancer-100368161","NCT04073706","Sentinel Node Biopsy in Endometrial Cancer","A Phase III Randomised Clinical Trial Comparing Sentinel Node Biopsy With No Retroperitoneal Node Dissection in Apparent Early-Stage Endometrial Cancer","ENDO-3","Inclusion Criteria:\n\n1. Females, over 18 years, with histologically confirmed primary epithelial cancer of the endometrium of any cell type or uterine carcinosarcoma (mixed malignant mullerian tumour);\n2. Clinically stage I disease (disease confined to body of uterus);\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n4. Signed written informed consent;\n5. Participant must meet criteria for a laparoscopic or robotic surgical approach as determined by the treating physician (e.g. suitable for TH BSO, ability to tolerate Trendelenberg positioning)\n6. All available clinical evidence (physical examination findings, or medical imaging such as CT, MRI or ultrasound) demonstrates no evidence of extrauterine disease\n7. Myometrial Invasion on MRI of not more than 50%. (Only if participant is \\\u003C45yo, has ONLY Grade 1 EAC and wishes to retain their ovaries).\n8. Negative (serum or urine) pregnancy test ≤ 30 days of surgery in pre-menopausal women and women \\\u003C 2 years after the onset of menopause.\n\nExclusion Criteria:\n\n1. Evidence of extrauterine disease (apparent involvement of cervix, vagina, parametria, adnexa, lymph nodes, bladder, bowel or distant sites) by clinical examination and\u002For through medical imaging.\n2. Enlarged retroperitoneal pelvic and\u002For aortic lymph nodes (\\>1 cm) on medical imaging;\n3. Estimated life expectancy of less than 6 months;\n4. Patients who have absolute contraindications for adjuvant radiotherapy and\u002For chemotherapy;\n5. Patients who have previously received radiation treatment to the pelvis\n6. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);\n7. Patient compliance and geographic proximity that do not allow adequate follow-up;\n8. Patients with allergy to Indocyanine Green (ICG)\n9. Patients who have had previous retroperitoneal surgery\n10. Patients who require a retroperitoneal (pelvic +\u002F- para-aortic) lymph node dissection (lymphadenectomy)\n11. Other prior malignancies \\\u003C5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma of the breast insitu\n12. Uterine perforation during endometrial tissue sampling",{"count":103,"type":21},760,[105],"PHASE3","Endometrial cancer (EC) is the most common gynaecological cancer. Current treatment of EC typically includes removal of the uterus and to determine the extent of the disease (removal of fallopian tubes, ovaries \\& if required a lymph node dissection (surgical staging)). While lymph node dissection may be valuable to guide the need for adjuvant treatment (chemo or radiotherapy) after surgery, it has been a topic of controversy for the last 30 years. In some patients it causes morbidity, specifically lymphoedema. This recently has been replaced with sentinel node biopsy (SNB). It requires an injection of a dye into the cervix with specific equipment \\& surgical dissection of the lymph node in which the dye first becomes visible. Despite this promising proposition \\& similar to a lymph node dissection, the value to patients, cost effectiveness \\& potential harms (e.g. lymphedema) of SNB compared to no-node dissection in EC has never been established. Aim: determine the value of SNB for patients, the healthcare system and exclude detriment to patients using a randomised approach 1:1. Stage 1 - 444 patients. Stage 2 additional 316 patients.\n\nPrimary Outcome Stage 1:\n\nProportion of participants returning to usual daily activities at 12 months from surgery using the EQ-5D which will determine when women in both groups can return to their usual activities.\n\nPrimary Outcome Stage 2:\n\nTreatment non-inferiority as evaluated by disease-free survival status at 4.5 years post-surgery, as measured by the time interval between the date of randomisation and date of first recurrence. Confirmation of recurrent disease will be ascertained through clinical assessment, radiological work-up and\u002For histological results.",[28,108,109],"Sentinel Lymph Node","Surgery",[111,112],"uterine cancer","sentinel node biopsy","2026-01-28",{"date":115,"type":60},"2026-01-30",{"date":117,"type":60},"2021-01-18",{"date":119,"type":21},"2031-02",{"name":121,"class":122},"Queensland Centre for Gynaecological Cancer","OTHER_GOV",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":133,"conditions":134,"keywords":137,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100426946","concurrent-laparoscopic-hysterectomy-and-weight-loss-surgery-in-obese-patients-with-endometrial-carcinoma-or-endometrial-intraepithelial-neoplasia-100426946","NCT04839614","Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia","Inclusion Criteria:\n\n* Female adults at least 18 years of age\n* A BMI of 35-39.99 and 1 or more severe obesity-related co-morbidities\n\n  --including T2D,112 hypertension, hyperlipidemia, obstructive sleep apnea (OSA), obesity-hypoventilation syndrome (OHS), Pickwickian syndrome (a combination of OSA and OHS), nonalcoholic 4 fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease (GERD), asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, or considerably impaired quality of life) OR a BMI ≥ 40\n* Tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma or EIN.\n\nExclusion Criteria:\n\n* Younger than 18 years old\n* BMI \\\u003C 35\n* Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis\n* Pregnant participants will be excluded from this study.\n* Patients with contraindications to bariatric surgery will also be excluded.\n\n  --This includes active smokers, prior bariatric surgery, active substance abuse, recent suicide attempt, bulimia nervosa, large abdominal hernias, or poorly controlled psychiatric illness\n* include inability to read an English informed consent form, and unwillingness to provide informed consent.",{"count":130,"type":21},30,[132],"NA","To assess the feasibility of an expedited referral process for the obese endometrial cancer or EIN patient from her gynecologic oncologist to the Brigham Center for Metabolic and Bariatric Surgery (CMBS) in order to undergo concurrent weight loss surgery and hysterectomy within 8 weeks of first appointment with a gynecologic oncologist (or 12 weeks for EIN patients).",[135,34,136,31,28],"Endometrial Carcinoma","EIN",[135,34,136,31,28,138,139],"Weight Loss Surgery","Bariatric Surgery","2025-08-04",{"date":142,"type":60},"2025-08-07",{"date":144,"type":60},"2021-08-01",{"date":146,"type":21},"2028-06-30",{"name":148,"class":67},"Dana-Farber Cancer Institute",2,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":165,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":149},"100596069","comparison-of-two-position-and-four-position-cervical-injection-techniques-for-sentinel-lymph-node-mapping-in-endometrial-cancer-using-methylene-blue-100596069","NCT07040657","Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue","Comparison of Two-Point and Four-Point Cervical Injection Techniques Using Methylene Blue for Sentinel Lymph Node Mapping in Endometrial Cancer","Inclusion Criteria:\n\n* Individuals diagnosed with stage I endometrial cancer based on CT and PET-CT imaging.\n* Individuals with a pathologically confirmed diagnosis of stage I endometrial cancer.\n\nExclusion Criteria:\n\nMedical Conditions\n\n* Individuals diagnosed with dementia.\n* Individuals with allergies to methylene blue or iodine.\n* Individuals who have received active treatment for another malignancy within the past five years.\n* Inability to successfully perform PLD (pelvic lymphadenectomy) or history of prior PLD.\n* Women with multiple and confluent lymph nodes identified as positive on FDG-PET\u002FCT (such cases are not considered stage I).\n\nCancer-Related Conditions\n\n* Individuals with clinically or radiologically identified positive lymph nodes or metastatic disease.\n* Individuals with a history of pelvic dissection and\u002For radiation therapy.\n* Individuals with advanced cervical or uterine cancer.\n* Individuals with T3\u002FT4 lesions.\n* Individuals with cervical tumors larger than 2 cm.\n\nOrgan Dysfunction\n\n• Individuals with hepatic dysfunction and a MELD score ≥ 10 and creatinine ≥ 2·0 mg\u002Fdl patients.","75 Years",{"count":159,"type":21},100,[132],"This clinical trial evaluates lymph node mapping in newly diagnosed endometrial cancer patients undergoing surgery. The standard technique uses a 2-point methylene blue cervical injection. The study aims to determine if increasing injection points improves mapping success.",[163,28,108,164],"Endometrial Neoplasms","Metastasis",[166,167,168,169],"endometrial neoplasm","methylene blue","metastasis","cervix","2025-06-18",{"date":172,"type":60},"2025-06-27",{"date":174,"type":60},"2025-05-01",{"date":176,"type":21},"2026-11-01",{"name":178,"class":67},"Dokuz Eylul University",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":157,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100453048","profiling-based-endometrial-cancer-adjuvant-therapy-100453048","NCT05179447","PROfiling Based Endometrial Cancer Adjuvant Therapy","Randomized Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Therapy for Women With Early Stage Endometrioid Adenocarcinoma","PROBEAT","Inclusion Criteria:\n\n1. Surgery consisting of a total abdominal or laparoscopic hysterectomy, bilateral salpingectomy, pelvic lymphadenectomy or sentinel lymph node mapping and dissection, with or without para-aortic lymphadenectomy, oophorectomy\n2. Histologically confirmed endometrioid type endometrial carcinoma, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I, with one of the following combinations of stage and grade:\n\n   Stage I A, grade 3 Stage I B, grade 1 or 2 Stage I B, grade 3 Stage II\n3. World Health Organization (WHO)-performance status 0-2\n4. Written informed consent\n\nExclusion Criteria:\n\n1. With residual disease\n2. Any other stage and type of endometrial carcinoma\n3. Histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma\n4. Uterine sarcoma (including carcinosarcoma)\n5. Previous malignancy (except for non-melanomatous skin cancer)\n6. Previous pelvic radiotherapy\n7. Expected interval between the operation and start of radiotherapy exceeding 8 weeks",{"count":188,"type":21},590,[132],"This is a prospective, multicenter, randomized phase III trial among women with endometrioid adenocarcinoma with high-intermediate and intermediate risk features to investigate the role of integrated genomic-pathologic classification to determine if participants should receive no adjuvant therapy, vaginal brachytherapy, external beam radiotherapy or chemo-radiation therapy based on molecular features as compared to standard radiation therapy.",[28,192],"Endometrial Cancer Stage II","2025-03-26",{"date":195,"type":60},"2025-04-01",{"date":197,"type":60},"2022-01-24",{"date":199,"type":21},"2027-01-01",{"name":201,"class":67},"Women's Hospital School Of Medicine Zhejiang University",10,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":214,"conditions":215,"keywords":219,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":228,"locationsCount":229},"100537517","phase-2-satellite-study-feasibility-safety-efficacy-dostarlimab-early-stage-deficient-endometrial-cancer-100537517","NCT06278857","SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)","A Phase 2b, Open-label, Single Arm, Multicentre, Pilot Study of the Efficacy, Safety and Tolerability of Dostarlimab in Women With Early-stage MMR Deficient Endometrioid Endometrial Adenocarcinoma.","SATELLITE","Inclusion Criteria:\n\n1. Female participant is at least 18 years of age (at the time of informed consent).\n2. Participant has:\n\n   i. histologically or cytologically proven Stage 1, FIGO grade 1 or 2, MMR deficient (Absence of at least one MMR protein (MLH1, PMS2, MSH2, MSH6) by immunohistochemistry.) endometrioid endometrial adenocarcinoma, and\n\n   ii. wish to preserve the uterus or are not a suitable candidate for hysterectomy.\n3. Participant has an ECOG performance status of ≤ 2\n4. Participant demonstrates no evidence of extrauterine disease assessed from all available clinical evidence (physical examination findings) and medical imaging including standard of care diagnostic CT, MRI, ultrasound, or X-ray and screening gadolinium contrast pelvic MRI\n5. Participants must have adequate organ and bone marrow function defined as:\n\n   i. absolute neutrophil count 1.5 x 109\u002FL ii. platelets 100 x 109\u002FL iii. haemoglobin ≥9 g\u002FdL\n\n   Adequate liver function:\n\n   iv. total bilirubin \\\u003C 1.5x institutional upper limit normal (ULN) v. AST\u002FALT \\\u003C 2. 5 - 3x ULN\n\n   Adequate renal function as defined by:\n\n   vi. Creatinine \\\u003C 1.5x institutional upper limits OR creatinine clearance \\> 30 ml\u002Fmin\n\n   Adequate coagulation profile:\n\n   vii. INR or PT ≤ 1.5 x ULN unless the participant is receiving anticoagulant therapy as long as INR or PTT is within the therapeutic range of intended use of anticoagulants viii. aPTT ≤ 1.5 x ULN unless the patient is receiving anticoagulant therapy as long as INR or PTT is within the therapeutic range of intended use of anticoagulant\n6. A potential participant with a clinical abnormality or laboratory parameters outside the normal reference range for the population being studied may be rescreened once, at the Investigator's discretion, and may be included only if the Investigator considers that the finding is unlikely to introduce additional risk factors to the participant and will not interfere with the study procedures.\n7. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at enrolment prior to each treatment cycle and use a highly effective contraceptive method including; oral contraceptive pills \\[OCPs\\], or an intrauterine hormone device \\[IUD\\]) from screening until at least 4 months following the last dose of dostarlimab. Females who are abstinent from heterosexual intercourse as part of their usual lifestyle do not need to use contraception.\n8. Post-menopausal females. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels (≥ 40 IU\u002FmL) at screening for amenorrhoeic (≥ 12 months) female participants.\n9. Participants with confirmed Type I or Type II diabetes mellitus must be well controlled by medication and\u002For diet and have glycated haemoglobin (HBAc1) \\\u003C 8.5% at screening and be willing to monitor blood glucose levels at home during study participation.\n10. Participants must have normal blood pressure (BP) or adequately treated and controlled hypertension.\n11. Participant is able to provide written informed consent and are willing to participate for the duration of the study and to follow study procedures.\n\nExclusion Criteria:\n\n1. Participant has a histological (cell) type other than endometrioid adenocarcinoma (sarcomas or high-risk endometrial e.g., papillary serous, clear cell).\n2. Participant is pregnant, breastfeeding, or planning to become pregnant during the trial period.\n3. Participant has had an allogeneic tissue\u002Fsolid organ transplant.\n4. Participants with uncontrolled hypertension, history of hypertension crisis, history of hypertensive encephalopathy, QTc\\>450 at baseline, other severe cardiovascular diseases including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, New York Heart Association (NYHA) class III and IV heart failure and uncontrolled arrhythmia within the past 6 months. Rate-controlled arrhythmia may be eligible at the discretion of the Investigator.\n5. Participant is considered a poor medical risk due to an uncontrolled medical disorder, non-malignant systemic disease, or active infection (including, r acute pelvic inflammatory disease), requiring intravenous antibiotics within the past 2 weeks. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).\n6. Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days before the study start.\n7. Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Use of inhaled steroids, local injection of steroids, and steroid eye drops are allowed.\n8. Participant with severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2; COVID-19) influenza A\u002FB within 3 months of screening.\n9. Participant received a transfusion of blood products (including platelets or red blood cells) within 21 days prior to the first dose of the study drug.\n10. Participant has undergone major surgery in the 4 weeks prior to consent.\n11. Participant has -experienced any of the following with prior immunotherapy: any immune-related AE (irAE) of Grade 3 or higher, immune-related severe neurologic events of any grade (e.g., myasthenic syndrome\u002Fmyasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms \\[DRESS\\] syndrome), or myocarditis of any grade. Non-clinically significant laboratory abnormalities are not exclusionary.)\n12. Participant has taken part in a clinical trial of an investigational medical product or device within 30 days or 5 half-lives before study start, whichever comes later. \\[except hormonal IUD\\]\n13. Participant has a concomitant malignancy, or participant has a prior non-endometrial invasive malignancy who has been disease-free for ≤5 years since end of treatment for the malignancy Non-melanoma skin cancer and definitively treated in-situ carcinomas is allowed.\n14. Participant has a known history of Human Immunodeficiency Virus (HIV), or a positive test at screening.\n15. Known active Hepatitis B or C, complete curative treatment and have no detectable viral RNA.\n16. Participants are known to be hypersensitive to the active substance or any of the excipients.\n17. Participant has a history or current diagnosis of interstitial lung disease.\n18. Participant has received or is scheduled to receive, a live vaccine within 30 days before the first dose of study treatment, during study treatment, and for up to 180 days after receiving the last dose of study treatment.\n19. Unwilling or unable to follow protocol requirements, including attendance at follow-up visit\u002Fs.\n20. Participant has any condition contraindicated with tumor \u002Fblood sampling procedures required by the protocol.",{"count":202,"type":21},[213],"PHASE2","The main goal of this clinical trial is to evaluate dostarlimab, an immunotherapy drug, as a potential alternative to surgery for early-stage endometrial cancer with Mismatch Repair deficiency, a genetic cause for 20-30% of cases. The study aims to establish dostarlimab's efficacy and safety in early-stage endometrial cancer, exploring its potential as a non surgical option for those unsuitable or unwilling to undergo major surgery, allowing for fertility preservation or addressing specific health conditions.\n\nParticipants will have seven dostarlimab sessions over 12 months. The treatment plan involves four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks.\n\nThis research is a promising step toward a new, less invasive treatment choice for patients with specific genetic traits. It expands the range of care options for endometrial cancer.",[28,216,217,218],"Mmr Deficiency","Endometrioid Endometrial Adenocarcinoma","Immune-related Adverse Event",[28,216,220,221],"Immunotherapy drug","Anti-programmed death receptor - 1(PD-1)","2024-12-02",{"date":224,"type":60},"2024-12-03",{"date":226,"type":60},"2024-08-01",{"date":146,"type":21},{"name":121,"class":122},3,{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},"100548187","prospective-study-for-endometrial-carcinoma-and-hyperplasia-in-childbearing-age-women-100548187","NCT06417736","Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women","Prospective Clinical Study of Fertility-sparing Treatment With a Membrane-inhibiting Formula Combined With Oral Progestins for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women","Inclusion Criteria:\n\n* 1.18-45 years old with a strong desire to preserve fertility; 2. pathologically diagnosed with primary grade1 or grade2 endometrioid endometrial carcinoma and hyperplasia 3.no signs of suspicious myometrial invasion by enhanced magnetic resonance imaging (MRI) 4. no signs of suspicious extrauterine metastasis by enhanced computed tomography and CT scan of the Lungs\n\nExclusion Criteria:\n\n* 1.have contraindication for pregnancy. 2.no fertility requiremen 3.have myometrial invasion or extrauterine metastasis 4.pathologically diagnosed with primary grade3 endometrioid endometrial carcinoma or non-endometrioid endometrial carcinoma 5.Any disease or symptom that may affect the implementation of the study or the interpretation of the results","45 Years",{"count":239,"type":21},75,[132],"The goal of this clinical trial is to evaluate the effect and adverse side effects of membrane-inhibiting formula plus oral progestins as fertility-preserving treatment in patients with early-stage endometrial cancer and endometrial hyperplasia research questions：When taken with oral progestins, does the drug membrane-inhibiting formula shorten the time required for complete endometrial remission? What medical problems do participants have when taking drug membrane-inhibiting formula plus oral progestins? Efficacy, side effects, recurrence, pregnancy, and time to obtain pregnancy in different molecular classifications of POLE-mutated, mismatch repair-deficient(MMRd), p53 wild type(p53wt), and p53-abnormal(p53abn).\n\nParticipants will: Take drug membrane-inhibiting formula plus oral progestins every day Visit the clinic once every 3 months for checkups, tests, and hysteroscopy Keep a diary of examination results and pathology",[28,243],"Endometrial Hyperplasia","2024-05-12",{"date":246,"type":60},"2024-05-16",{"date":248,"type":60},"2023-12-01",{"date":250,"type":21},"2026-12-31",{"name":201,"class":67},1]