[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gene-p53\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gene-p53":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100585301","sentinel-node-mapping-versus-comprehensive-lymphadenectomy-in-p53-mutated-endometrial-cancer-a-non-inferiority-randomized-trial-100585301",false,"NCT06900582","SENTInel Node Mapping Versus Comprehensive Lymphadenectomy in p53-Mutated Endometrial Cancer: A Non-Inferiority Randomized Trial","Comparing SENTInel Node Mapping to Comprehensive Lymphadenectomy in p53-Mutated EndoMETRial Cancer: a Prospective, Open-label, Controlled, Randomized, Non-inferiority, De-escalation Trial","SENTIMETREP53","Inclusion Criteria:\n\n1 . ≥ 18 years old 2. High-risk endometrial cancer, as defined by the ESGO-ESTRO 20211 histological and molecular classification, with p53 mutation confirmed on endometrial biopsy or curettage in the two months before the surgery 3. Magnetic Resonance Imaging (MRI) confirmed FIGO 2023 stage I and II endometrial cancer, i.e., confined to the uterine corpus, ovary and the cervical stroma.\n\n4\\. Participant with a scheduled surgical intervention (total hysterectomy and bilateral salpingo-oophorectomy, with omentectomy in the case of serous, carcinosarcoma and undifferenciated type EC) 5. Eligible for comprehensive lymphadenectomy by laparoscopy 6. Participant with a negative Positron Emission Tomography scan (PET-CT scan) for lymph node involvement in the two months before the intervention 7. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1 8. Participant able to provide written informed consent\n\nExclusion Criteria:\n\n1. Recurrent EC\n2. Previous chemo-, radio, or endocrine therapy for EC\n3. Any contra-indication to lymphadenectomy and\u002For chemotherapy\n4. Any contraindication to laparoscopy\n5. Any criteria, based on the investigator's judgment, that would contraindicate the surgical procedure (e.g., but not limited to, anesthetic risk, bleeding, significant comorbidities)\n6. Any known disorder or circumstances making participation in trial and follow-up questionable\n7. Patients with other malignancies for whom the disease(s) and\u002For associated treatment(s) might have an impact on the patient's cancer prognosis\n8. Known HIV-infection or AIDS\n9. Simultaneous participation in another interventional clinical trial\n10. Within the exclusion period following participation in another interventional clinical trial\n11. Patients with difficulties in reading or understanding French, or an inability to understand the delivered information\n12. Patients in emergency medical situations\n13. Patient under guardianship or limited guardianship","FEMALE","18 Years",{"count":20,"type":21},374,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study evaluates surgical strategies for treating patients with FIGO 2023 stage I and II high-risk endometrial cancer (EC) exhibiting p53 mutations. The trial aims to assess whether a less invasive sentinel lymph node (SLN) mapping approach provides non-inferior oncological outcomes compared to the current standard of systematic pelvic and para-aortic lymphadenectomy (PL+PALND). By minimizing surgical morbidity, this study seeks to determine if SLN mapping can safely replace comprehensive lymphadenectomy without compromising disease-free survival (DFS). Eligible patients will be randomized to undergo either sentinel lymph node mapping or complete lymphadenectomy, followed by standard hysterectomy and bilateral salpingo-oophorectomy. The primary outcome is DFS at 36 months, with secondary outcomes including overall survival, disease-specific survival, perioperative complications, and quality of life.",[27,28,29,30],"Lymphadenectomy","Endometrial Cancer","Gene, p53","Sentinel Lymph Node Biopsy (SLNB)",[32,33,27,34],"Endometrial cancer","Sentinel lymph node biopsy","p53 mutation","NOT_YET_RECRUITING","2026-02-13",{"date":38,"type":39},"2026-02-17","ACTUAL",{"date":41,"type":21},"2026-06",{"date":43,"type":21},"2031-10",{"name":45,"class":46},"University Hospital, Strasbourg, France","OTHER"]