protocolSection identificationModule nctId: NCT06264167, orgStudyIdInfo id: NODE, briefTitle: NODE (groiN ultrasOunD cancEr), acronym: NODE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Queensland Centre for Gynaecological Cancer, class: OTHER_GOV, collaborators name: Royal Brisbane and Women's Hospital, descriptionModule briefSummary: 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., conditionsModule conditions: Vulvar Cancer Stage Ib, conditions: Vulvar Cancer Stage II, conditions: Lymph Node Metastasis, conditions: Groin Node, conditions: Ultrasound Therapy; Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Feasibility trial, open label, three-group, randomised clinical trial30 eligible females aged 18 or older with clinically stage 1b or 2 vulvar cancer will receive a bilateral groin node ultrasound up to 30 days prior to planned surgery:Participants with normal/negative baseline groin ultrasounds will be randomly assigned to two groups (2:1 randomisation): one group undergoing radical procedures (groin lymph nodes are not removed) with bilateral groin ultrasound surveillance in conjunction with clinical examinations every 2 months, and the other group undergoing upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines).Participants with suspicious/indeterminate 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., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: High-resolution bilateral groin ultrasound surveillance, outcomesModule primaryOutcomes measure: Feasibility of randomisation: The percentage of patients willing to be randomised to either surgical groin node dissection or serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examination every 2 months., secondaryOutcomes measure: Utility of tumour mutations to determine positive lymph node metastasis., secondaryOutcomes measure: Utility of circulating tumour DNA to determine positive lymph node metastasis., secondaryOutcomes measure: Utility of plasma to determine positive lymph node metastasis., secondaryOutcomes measure: Utility of serum to determine positive lymph node metastasis., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St Andrew's War Memorial Hospital, city: Brisbane, state: Queensland, zip: 4000, country: Australia, contacts name: Sara Baniahmadi, role: CONTACT, phone: 07 3346 5073, email: s.baniahmadi@uq.edu.au, contacts name: Andreas Obermair, Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.46794, lon: 153.02809, locations facility: Royal Brisbane and Women's Hospital, city: Brisbane, state: Queensland, zip: 4029, country: Australia, contacts name: Sara Baniahmadi, role: CONTACT, phone: 07 3346 5073, email: s.baniahmadi@uq.edu.au, contacts name: Avalon Knott, role: CONTACT, phone: 07 3346 5073, email: a.knott@uq.edu.au, contacts name: Andrea Garrett, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.46794, lon: 153.02809, hasResults: False