[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543351":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":54,"collaborators":57,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":20,"enrollmentInfo":72,"targetDuration":20,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University Hospital, Gasthuisberg","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All women older than 18 newly diagnosed with endometrial cancer of all stages and histotypes","EXPERIMENTAL","All patients must undergo total hysterectomy and bilateral salpingo-oophorectomy or bilateral salpingectomy if premenopausal status and the lymph-node assessment according to European guidelines and local protocol. A comprehensive surgical peritoneal staging is required, which includes omentectomy\u002Fomental biopsies and six peritoneal biopsies.",[13],"Procedure: total hysterectomy with bilateral salpingo-oophorectomy, lymph node staging and comprehensive peritoneal staging",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","total hysterectomy with bilateral salpingo-oophorectomy, lymph node staging and comprehensive peritoneal staging","Surgical treatment will consist of total hysterectomy with bilateral salpingo-oophorectomy according to international guidelines.\n\nIn low- and intermediate-risk EC patients, staging will include a sentinel lymph node (SLN) procedure. In high intermediate-risk and high-risk EC patients, lymph node staging will involve SLN procedure and\u002For pelvic and para-aortic lymph node dissection (LND), depending on the local protocol.\n\nThe Study-related procedures include infracolic omentectomy or two separate omental representative biopsies, biopsies of all suspicious lesions as well as six peritoneal sites (bladder, pouch of Douglas, bilateral paracolic gutter and bilateral diaphragm).\n\nStage IV patients will be treated according to European guidelines. When feasible, full surgical intervention (i.e. debulking) is recommended. If this cannot be achieved, a radiologic and\u002For histologic confirmation of tumor spread beyond the uterus will be accepted.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Frédéric Amant, MD, PhD","UZ Leuven Gasthuisberg","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+3216342194","frederic.amant@uzleuven.be",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Ayaka Wakatsuki, Msc","+3216344169","ayaka.wakatsuki@uzleuven.be",[36],{"facility":37,"status":38,"city":39,"state":20,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"UZ Gasthuisberg, Katholieke Universiteit Leuven","RECRUITING","Leuven","3000","Belgium","BE",{"type":44,"coordinates":45},"Point",[46,47],4.70093,50.87959,{"lat":47,"lon":46},[50,53],{"name":51,"role":28,"phone":52,"phoneExt":20,"email":34},"Ayaka Wakatsuki","+32 16 34 41 69",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":25,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Frederic Amant","Head of the scientific Unit of Gynecologic Oncology, Full professor at Faculty of Medicine and Clinical Staff Specialist at Gynecological Oncology at UZ Leuven, Full professor at Faculty of Medicine, University of Amsterdam",[58,60],{"name":59,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"name":61,"class":6},"University Medical Centre Maribor","100543351","improving-endometrial-cancer-assessment-by-combining-genomic-profiling-and-surgical-assessment-100543351",false,"NCT06354738","Improving Endometrial Cancer Assessment by Combining Genomic Profiling and Surgical Assessment","Improving Endometrial Cancer Assessment by Combining the New techniqUe of GENomic Profiling With Surgical Extra uterIne disEase Assessment","EUGENIE","Inclusion Criteria:\n\n* Voluntary written informed consent of the participant or their legally authorized representative has been obtained before any screening procedures\n* Women ≥ 18 years\n* First diagnosis of EC, all disease stages and all histo-types\n\nExclusion Criteria:\n\n* Participant has a history of pelvic or para-aortic lymph node dissection or sampling, previous pelvic (and\u002For para-aortic) radiotherapy, previous neoadjuvant chemotherapy\n* Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol\n* Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Study","FEMALE","18 Years",{"count":73,"type":74},1000,"ESTIMATED","INTERVENTIONAL",[77],"NA","EUGENIE is a prospective multicentre interventional study, focused on improving endometrial cancer (EC) assessment by combining the new technique of genomic profiling with surgical extra uterine disease assessment. The investigators aim to correlate EC stage to each of the molecular subgroups of disease and thereby guide surgical treatment and staging of EC by determining the association between molecular classification and disease stage and evaluating if and how disease stage in each of the molecular subgroups associates with prognosis.",[80],"Endometrial Cancer",[80,82,83,84],"Genomic profiling","Molecular classification","Disease staging","2024-04-15",{"date":87,"type":88},"2024-04-17","ACTUAL",{"date":90,"type":88},"2023-01-16",{"date":92,"type":74},"2028-11-01",{"name":5,"class":6},1]