[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552711":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":33,"locations":42,"responsibleParty":189,"collaborators":191,"id":196,"slug":197,"hasResults":198,"nctId":199,"briefTitle":200,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":198,"sex":203,"minAge":204,"maxAge":18,"enrollmentInfo":205,"targetDuration":18,"studyType":208,"phases":209,"briefSummary":211,"conditions":212,"keywords":218,"overallStatus":221,"whyStopped":18,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},{"fullName":5,"class":6},"Queensland Centre for Gynaecological Cancer","OTHER_GOV",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with normal\u002Fnegative baseline groin ultrasounds - Intervention Group","EXPERIMENTAL","Surgical removal of primary tumour and serial high-resolution bilateral groin ultrasound monitoring every 2 months for 12 months, and at month 15 and month 18, with clinical examination at 8 weeks, 4 months, 8 months, 12 months, 15 months, and 18 months (n=360).",[13],"Diagnostic Test: High-resolution bilateral groin ultrasound monitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Participants with normal\u002Fnegative baseline groin ultrasounds - Standard Group","NO_INTERVENTION","Surgical removal of primary tumour and upfront full groin lymph node dissection (LND) or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines) (n=120).",null,{"label":20,"type":16,"description":21,"interventionNames":18},"Participants with suspicious\u002Findeterminate baseline groin ultrasound - Standard Treatment","Participants with suspicious\u002Findeterminate baseline groin ultrasound (third group) will receive an upfront full groin LND or SNB, consistent with the current standard treatment, according to local clinical practice management guidelines (n=160).",[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":18},"DIAGNOSTIC_TEST","High-resolution bilateral groin ultrasound monitoring","Participants in the Interventional Group will undergo surgical excision of the primary tumour, either via radical local excision or radical vulvectomy. Post-vulvar surgery, participants will receive a groin node ultrasound every 2 months for 12 months, and at month 15 and month 18, and a clinical examination at 8 weeks, 4 months, 8 months, 12 months, 15 months, and 18 months. Senior imaging specialists review bilateral ultrasound scans for positive lymph nodes or suspicious findings, promptly sending reports to the primary care physician and trial manager within 5 business days. If positive nodes are detected, participants will consult their primary care physician for options. Depending on clinical judgment, they may be referred for LND or continue with serial ultrasounds and clinical exams based on preference and clinician guidance.",[9],[29],{"name":30,"affiliation":31,"role":32},"Andreas Obermair, MD","Director, Queensland Centre for Gynaecological Cancer Research","STUDY_CHAIR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":18,"email":38},"Brianna Armstrong","CONTACT","+61 7 3346 5063","anvutrial@uq.edu.au",{"name":40,"role":36,"phone":41,"phoneExt":18,"email":38},"Sara Baniahmadi","+61 7 3346 5073",[43,63,78,98,115,126,140,156,172],{"facility":44,"status":18,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"John Hunter Hospital","Newcastle","New South Wales","2305","Australia","AU",{"type":51,"coordinates":52},"Point",[53,54],151.7801,-32.92953,{"lat":54,"lon":53},[57,60],{"name":58,"role":36,"phone":18,"phoneExt":18,"email":59},"Anne Mellon","anne.mellon@health.nsw.gov.au",{"name":61,"role":62,"phone":18,"phoneExt":18,"email":18},"Rachael O'Sullivan, MD","PRINCIPAL_INVESTIGATOR",{"facility":64,"status":18,"city":65,"state":66,"zip":67,"country":48,"countryCode":49,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"The Royal Darwin Hospital","Darwin","Northern Territory","0810",{"type":51,"coordinates":69},[70,71],130.84185,-12.46113,{"lat":71,"lon":70},[74,77],{"name":75,"role":36,"phone":18,"phoneExt":18,"email":76},"Michelle Harris, MD","Michelle.Harris2@nt.gov.au",{"name":75,"role":62,"phone":18,"phoneExt":18,"email":18},{"facility":79,"status":18,"city":80,"state":81,"zip":82,"country":48,"countryCode":49,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"The Wesley Hospital","Auchenflower","Queensland","4066",{"type":51,"coordinates":84},[85,86],152.99213,-27.47443,{"lat":86,"lon":85},[89,91,93,95],{"name":35,"role":36,"phone":37,"phoneExt":18,"email":90},"bri.armstrong@uq.edu.au",{"name":40,"role":36,"phone":41,"phoneExt":18,"email":92},"sara.baniahmadi@health.qld.gov.au",{"name":94,"role":62,"phone":18,"phoneExt":18,"email":18},"Andrea Garrett, MD",{"name":96,"role":97,"phone":18,"phoneExt":18,"email":18},"Rhett Morton, MD","SUB_INVESTIGATOR",{"facility":99,"status":18,"city":100,"state":81,"zip":101,"country":48,"countryCode":49,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"St Andrew's War Memorial Hospital","Brisbane","4000",{"type":51,"coordinates":103},[104,105],153.02809,-27.46794,{"lat":105,"lon":104},[108,110,113],{"name":35,"role":36,"phone":109,"phoneExt":18,"email":90},"07 3346 5063",{"name":40,"role":36,"phone":111,"phoneExt":18,"email":112},"0733465073","s.baniahmadi@uq.edu.au",{"name":114,"role":62,"phone":18,"phoneExt":18,"email":18},"Andreas Obermair, Prof",{"facility":116,"status":18,"city":100,"state":81,"zip":117,"country":48,"countryCode":49,"cosmosGeoPoint":118,"geoPoint":120,"contacts":121},"Royal Brisbane and Women's Hospital","4029",{"type":51,"coordinates":119},[104,105],{"lat":105,"lon":104},[122,123,125],{"name":35,"role":36,"phone":109,"phoneExt":18,"email":90},{"name":40,"role":36,"phone":124,"phoneExt":18,"email":112},"07 3346 5073",{"name":94,"role":62,"phone":18,"phoneExt":18,"email":18},{"facility":127,"status":18,"city":128,"state":81,"zip":129,"country":48,"countryCode":49,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Buderim Private Hospital","Buderim","4556",{"type":51,"coordinates":131},[132,133],153.05705,-26.68443,{"lat":133,"lon":132},[136,138,139],{"name":35,"role":36,"phone":137,"phoneExt":18,"email":90},"0733465063",{"name":40,"role":36,"phone":111,"phoneExt":18,"email":112},{"name":30,"role":62,"phone":18,"phoneExt":18,"email":18},{"facility":141,"status":18,"city":142,"state":143,"zip":144,"country":48,"countryCode":49,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Royal Adelaide Hospital","Adelaide","South Australia","5000",{"type":51,"coordinates":146},[147,148],138.59863,-34.92866,{"lat":148,"lon":147},[151,155],{"name":152,"role":36,"phone":153,"phoneExt":18,"email":154},"Martin Oehler","+61 8 8222 4816","martin.oehler@adelaide.edu.au",{"name":152,"role":62,"phone":18,"phoneExt":18,"email":18},{"facility":157,"status":18,"city":158,"state":159,"zip":160,"country":48,"countryCode":49,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Mercy Hospital for Women","Heidelberg","Victoria","3084",{"type":51,"coordinates":162},[163,164],145.06667,-37.75,{"lat":164,"lon":163},[167,170],{"name":168,"role":36,"phone":18,"phoneExt":18,"email":169},"Adam Pendlebury, MD","cgo@dradampendlebury.com.au",{"name":171,"role":62,"phone":18,"phoneExt":18,"email":18},"Adam Pendlebury",{"facility":173,"status":18,"city":174,"state":159,"zip":175,"country":48,"countryCode":49,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Royal Women's Hospital","Parkville","3052",{"type":51,"coordinates":177},[178,179],144.95,-37.78333,{"lat":179,"lon":178},[182,185,188],{"name":183,"role":36,"phone":18,"phoneExt":18,"email":184},"Estefania Vicario","estefania.vicario@thewomens.org.au",{"name":186,"role":36,"phone":18,"phoneExt":18,"email":187},"Niveditha Rajadevan, MD","niveditha.rajadevan@thewomens.org.au",{"name":186,"role":62,"phone":18,"phoneExt":18,"email":18},{"type":190,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[192,193],{"name":116,"class":6},{"name":194,"class":195},"The University of Queensland","OTHER","100552711","phase-3-a-phase-iii-randomised-clinical-trial-of-ultrasound-groin-monitoring-versus-groin-lymph-node-dissection-to-de-escalate-the-extent-of-surgery-in-vulvar-cancer-100552711",false,"NCT06476639","A Phase III Randomised Clinical Trial of Ultrasound Groin Monitoring Versus Groin Lymph Node Dissection to De-Escalate the Extent of Surgery in Vulvar Cancer","ANVU","Inclusion Criteria:\n\n* Females, over 18 years, with histologically confirmed SCC or adenocarcinoma of the vulva\n* Clinically stage 1b or 2 on medical imaging (CT or MRI scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease\n* Willing and able to undergo IFL\u002FSNB according to local clinical practice management guidelines\n* Willing and able to comply with all study requirements, timing and\u002For nature of required assessments.\n* Signed written informed consent\n* Negative (serum or urine) pregnancy (BHCG) test ≤ 30 days of surgery ONLY in pre-menopausal women and women \\\u003C 2 years after the onset of menopause.\n\nExclusion Criteria:\n\n* Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease)\n* Clinical or medical imaging evidence of regional and\u002For distant metastatic disease\n* Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)\n* Other prior malignancies \\\u003C5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ\n* Estimated life expectancy of ≤6 months","FEMALE","18 Years",{"count":206,"type":207},640,"ESTIMATED","INTERVENTIONAL",[210],"PHASE3","This study is a phase III, open label, multicentre, three-group, randomised clinical trial. The primary aim of this study is to determine whether intensive groin ultrasound monitoring (1) is effective and safe to replace invasive groin lymph node dissection (LND) to manage vulvar cancer, (2) decreases the morbidity associated with vulvar cancer surgery, and (3) is cost effective.",[213,214,215,216,217],"Vulvar Cancer Stage I","Vulvar Cancer Stage II","Lymph Node Metastasis","Groin Node","Ultrasound Therapy; Complications",[219,220],"Vulvar Cancer","Ultrasound Therapy","NOT_YET_RECRUITING","2026-03-19",{"date":224,"type":225},"2026-03-24","ACTUAL",{"date":227,"type":207},"2026-06-01",{"date":229,"type":207},"2035-12-31",{"name":5,"class":6},9]