[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536387":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":18,"centralContacts":28,"locations":38,"responsibleParty":116,"collaborators":118,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":126,"sex":132,"minAge":133,"maxAge":18,"enrollmentInfo":134,"targetDuration":18,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":147,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"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","EXPERIMENTAL","Interventional Treatment: serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examinations every 2 months (n=13).",[13],"Diagnostic Test: High-resolution bilateral groin ultrasound surveillance",{"label":15,"type":16,"description":17,"interventionNames":18},"Participants with normal\u002Fnegative baseline groin ultrasounds - Standard Care","NO_INTERVENTION","Standard Treatment: receive upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines) (n=7).",null,{"label":20,"type":16,"description":21,"interventionNames":18},"Participants with suspicious\u002Findeterminate baseline groin ultrasound","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=10).",[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":18},"DIAGNOSTIC_TEST","High-resolution bilateral groin ultrasound surveillance","Participants in the Interventional Treatment (serial ultrasounds) group will undergo surgical excision of the primary tumor, either via radical wide local excision or radical vulvectomy. Post-vulvar surgery, follow-up appointments occur bi-monthly for 12 months, involving a clinical examination and groin ultrasound. 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 if detected within 3 business days. Subsequently, participants consult their primary care physician for options. Depending on clinical judgment, they may be referred for LND or continue with bi-monthly ultrasounds based on preference and clinician guidance.",[9],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Sara Baniahmadi","CONTACT","07 3346 5073","s.baniahmadi@uq.edu.au",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Brianna Armstrong","07 3346 5063","bri.armstrong@uq.edu.au",[39,59,71,83,96],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"St Andrew's War Memorial Hospital","RECRUITING","Brisbane","Queensland","4000","Australia","AU",{"type":48,"coordinates":49},"Point",[50,51],153.02809,-27.46794,{"lat":51,"lon":50},[54,55,56],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},{"name":57,"role":58,"phone":18,"phoneExt":18,"email":18},"Andreas Obermair, Prof","PRINCIPAL_INVESTIGATOR",{"facility":60,"status":41,"city":42,"state":43,"zip":61,"country":45,"countryCode":46,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Royal Brisbane and Women's Hospital","4029",{"type":48,"coordinates":63},[50,51],{"lat":51,"lon":50},[66,67,69],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},{"name":68,"role":31,"phone":36,"phoneExt":18,"email":37},"Brianna armstrong",{"name":70,"role":58,"phone":18,"phoneExt":18,"email":18},"Andrea Garrett, Dr",{"facility":72,"status":73,"city":42,"state":43,"zip":74,"country":45,"countryCode":46,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"The Wesley Hospital","NOT_YET_RECRUITING","4066",{"type":48,"coordinates":76},[50,51],{"lat":51,"lon":50},[79,80,81],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},{"name":82,"role":58,"phone":18,"phoneExt":18,"email":18},"Andrea Garrett, MD",{"facility":84,"status":41,"city":85,"state":43,"zip":86,"country":45,"countryCode":46,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Buderim Private Hospital","Sunshine Coast","4556",{"type":48,"coordinates":88},[89,90],153.07955,-26.65682,{"lat":90,"lon":89},[93,94,95],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},{"name":57,"role":58,"phone":18,"phoneExt":18,"email":18},{"facility":97,"status":73,"city":98,"state":99,"zip":100,"country":45,"countryCode":46,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Royal Adelaide Hospital","Adelaide","South Australia","5000",{"type":48,"coordinates":102},[103,104],138.59863,-34.92866,{"lat":104,"lon":103},[107,111,114],{"name":108,"role":31,"phone":109,"phoneExt":18,"email":110},"Crystal Eldridge","(08) 7074 4404","crystal.eldridge@sa.gov.au",{"name":112,"role":31,"phone":109,"phoneExt":18,"email":113},"Kathy Heyman","kathy.heyman@sa.gov.au",{"name":115,"role":58,"phone":18,"phoneExt":18,"email":18},"Martin Oehler, Prof",{"type":117,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[119,120,122],{"name":60,"class":6},{"name":40,"class":121},"OTHER",{"name":84,"class":123},"UNKNOWN","100536387","node-groin-ultrasound-cancer-100536387",false,"NCT06264167","NODE (groiN ultrasOunD cancEr)","Randomised Feasibility Study of Groin Ultrasound Surveillance to De-Escalate Surgical Intervention in Women With Vulvar Cancer","NODE","Inclusion Criteria:\n\n* Women, over 18 years, with histologically confirmed SCC or adenocarcinoma of the vulva\n* Clinically stage I or II on medical imaging (CT scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease\n* Participant must be suitable to undergo IFL\u002FSNB according to local clinical practice management guidelines\n* Signed written informed consent\n* Negative serum pregnancy test ≤ 30 days of surgery in pre-menopausal women and women \\\u003C 2 years after the onset of menopause\n* Patient lives within 40 km of a medical diagnostic imaging centre (site investigator approval required for special circumstances)\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":135,"type":136},30,"ESTIMATED","INTERVENTIONAL",[139],"NA","This study is an open label, prospective, experimental, randomised clinical trial. The primary aim of this study is to determine whether it is feasible to randomise vulvar cancer patients into one of two treatment arms:1) surgical groin node dissection (as delivered though either a sentinel node biopsy or inguinofemoral lymph node dissection (IFL), or 2) serial high-resolution bilateral groin ultrasound surveillance and clinical examination every 2 months for 12 months.",[142,143,144,145,146],"Vulvar Cancer Stage Ib","Vulvar Cancer Stage II","Lymph Node Metastasis","Groin Node","Ultrasound Therapy; Complications",[148,149],"Vulvar Cancer","Ultrasound Therapy","2026-02-18",{"date":152,"type":153},"2026-02-20","ACTUAL",{"date":155,"type":153},"2024-07-01",{"date":157,"type":136},"2027-12-31",{"name":5,"class":6},5]