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NODE (groiN ultrasOunD cancEr)
Sponsor: Queensland Centre for Gynaecological Cancer
Summary
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.
Official title: Randomised Feasibility Study of Groin Ultrasound Surveillance to De-Escalate Surgical Intervention in Women With Vulvar Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-07-01
Completion Date
2027-12-31
Last Updated
2026-02-20
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (5)
St Andrew's War Memorial Hospital
Brisbane, Queensland, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
The Wesley Hospital
Brisbane, Queensland, Australia
Buderim Private Hospital
Sunshine Coast, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia