[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585301":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":30,"collaborators":25,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":34,"sex":40,"minAge":41,"maxAge":25,"enrollmentInfo":42,"targetDuration":25,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":54,"overallStatus":58,"whyStopped":25,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":25},{"fullName":5,"class":6},"University Hospital, Strasbourg, France","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sentinel Lymph Node Mapping","EXPERIMENTAL","Patients in this arm will undergo sentinel lymph node (SLN) mapping, followed by total hysterectomy, bilateral salpingo-oophorectomy, and, for serous, carcinosarcoma and undifferentiated type EC, infracolic omentectomy. The determination to perform para-aortic lymphadenectomy on SLN+ patients is left to the clinical team. Adjuvant treatment will depend of the status.",[13],"Procedure: Sentinel Lymph Node Mapping",{"label":15,"type":16,"description":17,"interventionNames":18},"Complete lymphadenectomy","ACTIVE_COMPARATOR","Patients in this arm will undergo comprehensive pelvic and para-aortic lymphadenectomy that extends up to the left renal vein, followed by total hysterectomy and bilateral salpingo-oophorectomy, with omentectomy for serous, carcinosarcoma and undifferentiated type EC. Adjuvant treatment will depend of the status.",[19],"Procedure: Comprehensive pelvic and para-aortic lymphadenectomy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","The SLN mapping protocol will follow the EU guidelines and the consensus in competency assessment tool. Prior to SLN mapping, a full inspection of the pelvic areas with white light is performed to exclude the presence of extrauterine disease. The next surgical steps will be 1- identification of external iliac vessels, 2- identification of internal iliac artery, 3- dissection of the ureter, 4- development of paravesical space and 5- identification of obliterated umbilical ligament. The dissection technique must avoid disrupting lymphatic channels and isolate nodal tissue from the local anatomy. Indocyanine green (1.25mg\u002FmL) will be injected in the cervix at the 3 and 9 o'clock positions, with 1mL superficial and 1mL deep, for a total of 4mL. All mapped SLNs must be completely excised, and any visually suspicious nodes should also be removed, regardless of the mapping results. If the SLN mapping appears to be unfeasible, a side-specific pelvic lymphadenectomy will be performed.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Comprehensive pelvic and para-aortic lymphadenectomy","The resection of at least one lymph node in each of the 12 retroperitoneal regions is necessary:\n\nA: upper para-aortic region B: lower para-aortic region C: interaorto-caval region D: paracaval region E: right and left iliaca communis region F: right and left iliaca externa region G: right and left fossa obturatoria region: defined by external and internal arteria iliaca, pelvic sidewall H: right and left iliaca interna region: lymph nodes adjacent to or medial of the internal iliacal artery",[15],{"type":31,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":43,"type":44},374,"ESTIMATED","INTERVENTIONAL",[47],"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.",[50,51,52,53],"Lymphadenectomy","Endometrial Cancer","Gene, p53","Sentinel Lymph Node Biopsy (SLNB)",[55,56,50,57],"Endometrial cancer","Sentinel lymph node biopsy","p53 mutation","NOT_YET_RECRUITING","2026-02-13",{"date":61,"type":62},"2026-02-17","ACTUAL",{"date":64,"type":44},"2026-06",{"date":66,"type":44},"2031-10",{"name":5,"class":6}]