[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100384892":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":22,"centralContacts":26,"locations":35,"responsibleParty":268,"collaborators":10,"id":270,"slug":271,"hasResults":272,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":10,"eligibilityCriteria":276,"healthyVolunteers":272,"sex":277,"minAge":278,"maxAge":10,"enrollmentInfo":279,"targetDuration":10,"studyType":282,"phases":10,"briefSummary":283,"conditions":284,"keywords":288,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":299},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Part 1",null,"Participants will have endometrioid adenocarcinoma histological diagnosis with planned surgical treatment including hysterectomy in combination with SLN biopsy.",{"label":13,"type":10,"description":14,"interventionNames":15},"Part 2","Participants will have undergone surgery and bilateral sentinel lymph node mapping (negative for malignancy)",[16],"Other: Physical exam",[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"Physical exam","Part 2 participants will be prospectively followed clinically for relapse for 30 months from the date of surgery for physical examination at post-ops visits.",[13],[23],{"name":24,"affiliation":5,"role":25},"Nadeem Abu-Rustum, MD","PRINCIPAL_INVESTIGATOR",[27,31],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":30},"CONTACT","212-639-7051","abu-rusn@mskcc.org",{"name":32,"role":28,"phone":33,"phoneExt":10,"email":34},"Mario Leitao, MD","212-639-3987","leitaom@mskcc.org",[36,54,69,79,92,103,115,126,137,149,160,169,180,194,204,218,230,242,254],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hartford Healthcare Cancer Institute @ Hartford Hospital","RECRUITING","Hartford","Connecticut","06102","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-72.68509,41.76371,{"lat":48,"lon":47},[51],{"name":52,"role":28,"phone":53,"phoneExt":10,"email":10},"Jonathan Cosin, MD","860-826-1101",{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":42,"countryCode":43,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"University of Miami (Data Collection Only)","NOT_YET_RECRUITING","Miami","Florida","33136",{"type":45,"coordinates":61},[62,63],-80.19366,25.77427,{"lat":63,"lon":62},[66],{"name":67,"role":28,"phone":68,"phoneExt":10,"email":10},"Brian Clomovitz, MD","305-243-2233",{"facility":70,"status":38,"city":57,"state":58,"zip":71,"country":42,"countryCode":43,"cosmosGeoPoint":72,"geoPoint":74,"contacts":75},"Miami Cancer Institute Baptist Health South Florida","33143",{"type":45,"coordinates":73},[62,63],{"lat":63,"lon":62},[76],{"name":77,"role":28,"phone":78,"phoneExt":10,"email":10},"John Paul Diaz, MD","786-596-2000",{"facility":80,"status":38,"city":81,"state":58,"zip":82,"country":42,"countryCode":43,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"ADVENTHEALTH (Data collection only)","Orlando","32804",{"type":45,"coordinates":84},[85,86],-81.37924,28.53834,{"lat":86,"lon":85},[89],{"name":90,"role":28,"phone":91,"phoneExt":10,"email":10},"Robert Holloway, MD","407-303-2422",{"facility":93,"status":94,"city":95,"state":96,"zip":97,"country":42,"countryCode":43,"cosmosGeoPoint":98,"geoPoint":102,"contacts":10},"Mayo Clinic (Data Collection and Data Analysis)","ACTIVE_NOT_RECRUITING","Rochester","Minnesota","55905",{"type":45,"coordinates":99},[100,101],-92.4699,44.02163,{"lat":101,"lon":100},{"facility":104,"status":38,"city":105,"state":106,"zip":107,"country":42,"countryCode":43,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Memorial Sloan Kettering Basking Ridge (All protocol activities)","Basking Ridge","New Jersey","07920",{"type":45,"coordinates":109},[110,111],-74.54932,40.70621,{"lat":111,"lon":110},[114],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":10},{"facility":116,"status":38,"city":117,"state":106,"zip":118,"country":42,"countryCode":43,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Memorial Sloan Kettering Monmouth (All protocol activities)","Middletown","07748",{"type":45,"coordinates":120},[121,122],-74.11709,40.39428,{"lat":122,"lon":121},[125],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":10},{"facility":127,"status":38,"city":128,"state":106,"zip":129,"country":42,"countryCode":43,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Memorial Sloan Kettering Bergen (All protocol activities)","Montvale","07645",{"type":45,"coordinates":131},[132,133],-74.02292,41.04676,{"lat":133,"lon":132},[136],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":10},{"facility":138,"status":38,"city":139,"state":140,"zip":141,"country":42,"countryCode":43,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Memorial Sloan Kettering Commack (All Protocol Activities)","Commack","New York","11725",{"type":45,"coordinates":143},[144,145],-73.29289,40.84288,{"lat":145,"lon":144},[148],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":10},{"facility":150,"status":38,"city":151,"state":140,"zip":152,"country":42,"countryCode":43,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Memorial Sloan Kettering Westchester (All protocol activities)","Harrison","10604",{"type":45,"coordinates":154},[155,156],-73.71263,40.96899,{"lat":156,"lon":155},[159],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":10},{"facility":5,"status":38,"city":140,"state":140,"zip":161,"country":42,"countryCode":43,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"10065",{"type":45,"coordinates":163},[164,165],-74.00597,40.71427,{"lat":165,"lon":164},[168],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":10},{"facility":170,"status":38,"city":171,"state":140,"zip":172,"country":42,"countryCode":43,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Memorial Sloan Kettering Nassau (All protocol activities)","Rockville Centre","11553",{"type":45,"coordinates":174},[175,176],-73.64124,40.65871,{"lat":176,"lon":175},[179],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":10},{"facility":181,"status":38,"city":182,"state":183,"zip":184,"country":42,"countryCode":43,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Lehigh Valley Health Network","Allentown","Pennsylvania","18103",{"type":45,"coordinates":186},[187,188],-75.49018,40.60843,{"lat":188,"lon":187},[191],{"name":192,"role":28,"phone":193,"phoneExt":10,"email":10},"Martin Martino, MD","610-402-3650",{"facility":195,"status":196,"city":197,"state":10,"zip":10,"country":198,"countryCode":10,"cosmosGeoPoint":199,"geoPoint":203,"contacts":10},"Charles University and General University Hospital (Data Collection Only)","TERMINATED","Prague","Czechia",{"type":45,"coordinates":200},[201,202],14.42076,50.08804,{"lat":202,"lon":201},{"facility":205,"status":38,"city":206,"state":10,"zip":10,"country":207,"countryCode":208,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"OSPEDALE MICHELE E PIETRO (Data Collection Only)","Ferrera","Italy","IT",{"type":45,"coordinates":210},[211,212],8.1879,45.86699,{"lat":212,"lon":211},[215],{"name":216,"role":28,"phone":217,"phoneExt":10,"email":10},"Alessandro Buda, MD","0173 290851",{"facility":219,"status":56,"city":220,"state":10,"zip":10,"country":207,"countryCode":208,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"UNIVERSITY OF MILANO-BICOCCA, ITALY (Data Collection)","Milan",{"type":45,"coordinates":222},[223,224],9.18951,45.46427,{"lat":224,"lon":223},[227],{"name":228,"role":28,"phone":229,"phoneExt":10,"email":10},"Tommaso Grassi, MD","+39 02 6448 6099",{"facility":231,"status":56,"city":232,"state":10,"zip":10,"country":207,"countryCode":208,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"FONDAZIONE POLICLINICOUNIVERSITARIO A. GEMELLI, ITALY (Data Collection Only)","Roma",{"type":45,"coordinates":234},[235,236],11.10642,44.99364,{"lat":236,"lon":235},[239],{"name":240,"role":28,"phone":241,"phoneExt":10,"email":10},"Giovanni Scambia, MD","39 06 30151",{"facility":243,"status":38,"city":244,"state":10,"zip":10,"country":207,"countryCode":208,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"L'Azienda Sanitaria Universitaria Friuli Centrale","Udine",{"type":45,"coordinates":246},[247,248],13.23715,46.0693,{"lat":248,"lon":247},[251],{"name":252,"role":28,"phone":10,"phoneExt":10,"email":253},"Giuseppe Vizzielli, MD","giuseppe.vizzielli@asufc.sanita.fvg.it",{"facility":255,"status":56,"city":256,"state":10,"zip":10,"country":257,"countryCode":258,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)","Oslo","Norway","NO",{"type":45,"coordinates":260},[261,262],10.74609,59.91273,{"lat":262,"lon":261},[265],{"name":266,"role":28,"phone":267,"phoneExt":10,"email":10},"Ane Gerda, MD, PhD","+47 22 93 44 46",{"type":269,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100384892","observational-study-of-women-with-endometrial-cancer-who-receive-the-standard-treatment-for-their-disease-100384892",false,"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","FEMALE","18 Years",{"count":280,"type":281},1715,"ESTIMATED","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.",[285,286,287],"Endometrial Cancer","Endometrioid Adenocarcinoma","Endometrial Cancer Stage I",[285,286,289,5],"20-067","2026-03-27",{"date":292,"type":293},"2026-04-01","ACTUAL",{"date":295,"type":293},"2020-02-26",{"date":297,"type":281},"2027-02-26",{"name":5,"class":6},19]