[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100368161":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":393,"collaborators":395,"id":399,"slug":400,"hasResults":401,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":401,"sex":407,"minAge":408,"maxAge":26,"enrollmentInfo":409,"targetDuration":26,"studyType":412,"phases":413,"briefSummary":415,"conditions":416,"keywords":420,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":432},{"fullName":5,"class":6},"Queensland Centre for Gynaecological Cancer","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TH BSO with SNB","EXPERIMENTAL","Total Laparoscopic\u002FRobotic Hysterectomy, Bilateral Salpingo-Oophorectomy (TH BSO) with Sentinel Node Biopsy (SNB) using Indocyanine Green (ICG)+\u002F- Methylene Blue Dye (+\u002F- omentectomy in high risk cell types) Note: If participants (≤45 years of age), have Grade 1 endometrial adenocarcinoma (EAC) with myometrial invasion \\\u003C50% (by MRI) and wish to retain their ovaries a BSO may be omitted.",[13],"Procedure: TH BSO with SNB Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion \u003C50%, wish to retain their ovaries a BSO may be omitted",{"label":15,"type":16,"description":17,"interventionNames":18},"TH BSO without retroperitoneal node dissection","ACTIVE_COMPARATOR","Total Laparoscopic\u002FRobotic Hysterectomy, Bilateral Salpingo-Oophorectomy (TH BSO) without retroperitoneal node dissection (+\u002F- omentectomy in high risk cell types) Note: If participants (≤45 years of age), have Grade 1 endometrial adenocarcinoma (EAC) with myometrial invasion \\\u003C50% (by MRI) and wish to retain their ovaries a BSO may be omitted.",[19],"Procedure: TH BSO without retroperitoneal node dissection Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion \u003C50%, wish to retain their ovaries a BSO may be omitted",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","TH BSO with SNB Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion \u003C50%, wish to retain their ovaries a BSO may be omitted","Removal of uterus, tubes and ovaries with a sentinel node biopsy. A tracer dye (ICG) +\u002F- Methylene Blue Dye is injected into the surroundings of the primary tumour, it is transported via local lymphatic channels towards the draining lymphatic basin, and the first node that the tracer reaches is called the \"sentinel node\". These one or two nodes are thought to be first involved with cancer spread.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"TH BSO without retroperitoneal node dissection Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion \u003C50%, wish to retain their ovaries a BSO may be omitted","Removal of uterus, tubes and ovaries without retroperitoneal node dissection",[15],[32],{"name":33,"affiliation":34,"role":35},"Andreas Obermair, Prof","Director, Queensland Centre for Gynaecological Cancer Research","STUDY_CHAIR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Grace Ngiam","CONTACT","+61 7 3346 5590","endo3trial@uq.edu.au",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Sara Baniahmadi","+61733465073","sara.baniahmadi@health.qld.gov.au",[47,82,99,119,133,151,165,180,199,220,234,247,265,284,301,316,328,348,369],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Houston Methodist Hospital","RECRUITING","Houston","Texas","77030","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-95.36327,29.76328,{"lat":59,"lon":58},[62,66,70,73,76,78,80],{"name":63,"role":39,"phone":64,"phoneExt":26,"email":65},"Jaya Kamath","713-441-6616","jskamath@houstonmethodist.org",{"name":67,"role":39,"phone":68,"phoneExt":26,"email":69},"Konny Fong","346.238.5815","klchanfong@houstonmethodist.org",{"name":71,"role":72,"phone":26,"phoneExt":26,"email":26},"Behrouz Zand, MD","PRINCIPAL_INVESTIGATOR",{"name":74,"role":75,"phone":26,"phoneExt":26,"email":26},"Tarrik Zaid, MD","SUB_INVESTIGATOR",{"name":77,"role":75,"phone":26,"phoneExt":26,"email":26},"Aparna Kamat, MD",{"name":79,"role":75,"phone":26,"phoneExt":26,"email":26},"Anju Suri, MD",{"name":81,"role":75,"phone":26,"phoneExt":26,"email":26},"Pedro Ramirez, MD",{"facility":83,"status":84,"city":85,"state":86,"zip":26,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Hospital Britanico","NOT_YET_RECRUITING","Buenos Aires","Ciudad Autónoma de Buenos Aires (caba)","Argentina","AR",{"type":56,"coordinates":90},[91,92],-58.37723,-34.61315,{"lat":92,"lon":91},[95,98],{"name":96,"role":39,"phone":26,"phoneExt":26,"email":97},"Julian Di Guilmi, MD","Jdiguilmi@hbritanico.com.ar",{"name":96,"role":72,"phone":26,"phoneExt":26,"email":26},{"facility":100,"status":49,"city":101,"state":102,"zip":103,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Chris O'Brien Lifehouse","Camperdown","New South Wales","2050","Australia","AU",{"type":56,"coordinates":107},[108,109],151.17642,-33.88965,{"lat":109,"lon":108},[112,115,118],{"name":113,"role":39,"phone":26,"phoneExt":26,"email":114},"Rhonda Farrell, MD","rhondafarrell@mac.com",{"name":116,"role":39,"phone":26,"phoneExt":26,"email":117},"Sadaf Kalam","sadaf.kalam@lh.org.au",{"name":113,"role":72,"phone":26,"phoneExt":26,"email":26},{"facility":120,"status":49,"city":121,"state":102,"zip":122,"country":104,"countryCode":105,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Liverpool Hospital","Liverpool","2170",{"type":56,"coordinates":124},[125,126],150.92588,-33.91938,{"lat":126,"lon":125},[129,132],{"name":130,"role":39,"phone":26,"phoneExt":26,"email":131},"Michael Burling, MD","michael.burling@health.nsw.gov.au",{"name":130,"role":72,"phone":26,"phoneExt":26,"email":26},{"facility":134,"status":49,"city":135,"state":136,"zip":137,"country":104,"countryCode":105,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"The Wesley Hospital","Auchenflower","Queensland","4066",{"type":56,"coordinates":139},[140,141],152.99213,-27.47443,{"lat":141,"lon":140},[144,145,147,149],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":43,"role":39,"phone":146,"phoneExt":26,"email":45},"+61 7 3346 5073",{"name":148,"role":72,"phone":26,"phoneExt":26,"email":26},"Andrea Garrett, MD",{"name":150,"role":75,"phone":26,"phoneExt":26,"email":26},"Rhett Morton, MD",{"facility":152,"status":49,"city":153,"state":136,"zip":154,"country":104,"countryCode":105,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Buderim Private Hospital","Buderim","4556",{"type":56,"coordinates":156},[157,158],153.05705,-26.68443,{"lat":158,"lon":157},[161,162,163],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"name":164,"role":72,"phone":26,"phoneExt":26,"email":26},"Andreas Obermair, MD",{"facility":166,"status":49,"city":167,"state":136,"zip":168,"country":104,"countryCode":105,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"North West Private Hospital","Everton Park","4053",{"type":56,"coordinates":170},[171,172],152.9884,-27.40732,{"lat":172,"lon":171},[175,177,178],{"name":38,"role":39,"phone":176,"phoneExt":26,"email":41},"0733465590",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"name":179,"role":72,"phone":26,"phoneExt":26,"email":26},"Piksi Singh, MD",{"facility":181,"status":49,"city":182,"state":136,"zip":183,"country":104,"countryCode":105,"cosmosGeoPoint":184,"geoPoint":188,"contacts":189},"Royal Brisbane and Women's Hospital","Herston","4029",{"type":56,"coordinates":185},[186,187],153.01852,-27.44453,{"lat":187,"lon":186},[190,191,192,193,194,196,197],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"name":148,"role":72,"phone":26,"phoneExt":26,"email":26},{"name":164,"role":75,"phone":26,"phoneExt":26,"email":26},{"name":195,"role":75,"phone":26,"phoneExt":26,"email":26},"Russell Land, MD",{"name":179,"role":75,"phone":26,"phoneExt":26,"email":26},{"name":198,"role":75,"phone":26,"phoneExt":26,"email":26},"Shaun McGrath, MD",{"facility":200,"status":49,"city":201,"state":136,"zip":202,"country":104,"countryCode":105,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Mater Hospital","South Brisbane","4101",{"type":56,"coordinates":204},[205,206],153.02049,-27.48034,{"lat":206,"lon":205},[209,210,211,213,215,217,218],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"name":212,"role":72,"phone":26,"phoneExt":26,"email":26},"Naven Chetty, MD",{"name":214,"role":75,"phone":26,"phoneExt":26,"email":26},"Nisha Jagasia, MD",{"name":216,"role":75,"phone":26,"phoneExt":26,"email":26},"Nimithri Cabraal, MD",{"name":150,"role":75,"phone":26,"phoneExt":26,"email":26},{"name":219,"role":75,"phone":26,"phoneExt":26,"email":26},"Simon West, MD",{"facility":221,"status":84,"city":222,"state":136,"zip":223,"country":104,"countryCode":105,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Gold Coast University Hospital","Southport","4215",{"type":56,"coordinates":225},[226,227],153.39796,-27.96724,{"lat":227,"lon":226},[230,231,232],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"name":233,"role":72,"phone":26,"phoneExt":26,"email":26},"Elizabeth Goulding, MD",{"facility":235,"status":49,"city":236,"state":136,"zip":237,"country":104,"countryCode":105,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"St Andrews War Memorial Hospital","Spring Hill","4000",{"type":56,"coordinates":239},[240,241],153.02311,-27.46141,{"lat":241,"lon":240},[244,245,246],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"name":164,"role":72,"phone":26,"phoneExt":26,"email":26},{"facility":248,"status":49,"city":249,"state":250,"zip":251,"country":104,"countryCode":105,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"Mercy Hospital for Women","Heidelberg","Victoria","3084",{"type":56,"coordinates":253},[254,255],145.06667,-37.75,{"lat":255,"lon":254},[258,261,264],{"name":259,"role":39,"phone":26,"phoneExt":26,"email":260},"Adam Pendlebury, MD","cgo@dradampendlebury.com.au",{"name":262,"role":39,"phone":26,"phoneExt":26,"email":263},"Carla Starmans","Cstarmans@mercy.com.au",{"name":259,"role":72,"phone":26,"phoneExt":26,"email":26},{"facility":266,"status":49,"city":267,"state":250,"zip":268,"country":104,"countryCode":105,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"Royal Women's Hospital","Parkville","3052",{"type":56,"coordinates":270},[271,272],144.95,-37.78333,{"lat":272,"lon":271},[275,278,281,282],{"name":276,"role":39,"phone":26,"phoneExt":26,"email":277},"Estefania Vicario","estefania.vicario@thewomens.org.au",{"name":279,"role":39,"phone":26,"phoneExt":26,"email":280},"Orla McNally, MD","Orla.McNally@thewomens.org.au",{"name":279,"role":72,"phone":26,"phoneExt":26,"email":26},{"name":283,"role":75,"phone":26,"phoneExt":26,"email":26},"Deborah Neesham, MD",{"facility":285,"status":49,"city":286,"state":287,"zip":288,"country":289,"countryCode":290,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"Hospital de Base","São José do Rio Preto","São Paulo","15090-000","Brazil","BR",{"type":56,"coordinates":292},[293,294],-49.37944,-20.81972,{"lat":294,"lon":293},[297,300],{"name":298,"role":39,"phone":26,"phoneExt":26,"email":299},"Guilherme Accorsi, MD","dr.guilhermeaccorsi@gmail.com",{"name":298,"role":72,"phone":26,"phoneExt":26,"email":26},{"facility":302,"status":49,"city":287,"state":287,"zip":26,"country":289,"countryCode":290,"cosmosGeoPoint":303,"geoPoint":307,"contacts":308},"Fundacao Antonio Prudente, AC Camargo Cancer Center",{"type":56,"coordinates":304},[305,306],-46.63611,-23.5475,{"lat":306,"lon":305},[309,312,315],{"name":310,"role":39,"phone":26,"phoneExt":26,"email":311},"Glauco Baiocchi Neto, MD","glauco.baiocchi@accamargo.org.br",{"name":313,"role":39,"phone":26,"phoneExt":26,"email":314},"Bruna Goncalves","bruna.goncalves@accamargo.org.br",{"name":310,"role":72,"phone":26,"phoneExt":26,"email":26},{"facility":317,"status":84,"city":287,"state":287,"zip":26,"country":289,"countryCode":290,"cosmosGeoPoint":318,"geoPoint":320,"contacts":321},"Hospital Israelita Albert Einstein",{"type":56,"coordinates":319},[305,306],{"lat":306,"lon":305},[322,325,327],{"name":323,"role":39,"phone":26,"phoneExt":26,"email":324},"Renato Moretti-Marques, MD","morettimarques@gmail.com",{"name":326,"role":39,"phone":26,"phoneExt":26,"email":26},"Renato",{"name":323,"role":72,"phone":26,"phoneExt":26,"email":26},{"facility":329,"status":49,"city":330,"state":331,"zip":332,"country":333,"countryCode":334,"cosmosGeoPoint":335,"geoPoint":339,"contacts":340},"Centro de tratamiento e investigación sobre Cáncer Luis Carlos Sarmiento Angulo","Bogotá","Bogotá, Distrito Capital","110131","Colombia","CO",{"type":56,"coordinates":336},[337,338],-74.08175,4.60971,{"lat":338,"lon":337},[341,344,347],{"name":342,"role":39,"phone":26,"phoneExt":26,"email":343},"David Viveros, MD","dviverosc@gmail.com",{"name":345,"role":39,"phone":26,"phoneExt":26,"email":346},"Briegal De Las Calderon","bcalderon@fctic.org",{"name":342,"role":72,"phone":26,"phoneExt":26,"email":26},{"facility":349,"status":49,"city":350,"state":351,"zip":352,"country":353,"countryCode":354,"cosmosGeoPoint":355,"geoPoint":359,"contacts":360},"Azienda Sanitaria Universitaria Friuli Centrale (ASUFC)","Udine","Via Pozzuolo","33100","Italy","IT",{"type":56,"coordinates":356},[357,358],13.23715,46.0693,{"lat":358,"lon":357},[361,364,367,368],{"name":362,"role":39,"phone":26,"phoneExt":26,"email":363},"Stefano Restaino, MD","stefano.restaino@asufc.sanita.fvg.it",{"name":365,"role":39,"phone":26,"phoneExt":26,"email":366},"Giuseppe Vizzielli, MD","giuseppe.vizzielli@asufc.sanita.fvg.it",{"name":365,"role":72,"phone":26,"phoneExt":26,"email":26},{"name":362,"role":75,"phone":26,"phoneExt":26,"email":26},{"facility":370,"status":49,"city":371,"state":372,"zip":373,"country":371,"countryCode":374,"cosmosGeoPoint":375,"geoPoint":379,"contacts":380},"National University Hospital and National University Cancer Institute","Singapore","NUH Zone B","119074","SG",{"type":56,"coordinates":376},[377,378],103.85007,1.28967,{"lat":378,"lon":377},[381,384,387,388,389,391],{"name":382,"role":39,"phone":26,"phoneExt":26,"email":383},"Joseph Ng Soon Yau, MD","obgnsyj@nus.edu.sg",{"name":385,"role":39,"phone":26,"phoneExt":26,"email":386},"Pearl S Tong, MD","pearl_sy_tong@nuhs.edu.sg",{"name":382,"role":72,"phone":26,"phoneExt":26,"email":26},{"name":385,"role":75,"phone":26,"phoneExt":26,"email":26},{"name":390,"role":75,"phone":26,"phoneExt":26,"email":26},"Jeffrey Low, MD",{"name":392,"role":75,"phone":26,"phoneExt":26,"email":26},"Jeslyn Wong, MD",{"type":394,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[396],{"name":397,"class":398},"The University of Queensland","OTHER","100368161","phase-3-sentinel-node-biopsy-in-endometrial-cancer-100368161",false,"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","FEMALE","18 Years",{"count":410,"type":411},760,"ESTIMATED","INTERVENTIONAL",[414],"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.",[417,418,419],"Endometrial Cancer Stage I","Sentinel Lymph Node","Surgery",[421,422],"uterine cancer","sentinel node biopsy","2026-01-28",{"date":425,"type":426},"2026-01-30","ACTUAL",{"date":428,"type":426},"2021-01-18",{"date":430,"type":411},"2031-02",{"name":5,"class":6},19]