30
Participants
Start Date
July 1, 2024
Primary Completion Date
March 31, 2026
Study Completion Date
March 31, 2028
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.
RECRUITING
St Andrew's War Memorial Hospital, Brisbane
RECRUITING
Royal Brisbane and Women's Hospital, Brisbane
RECRUITING
Buderim Private Hospital, Sunshine Coast
Royal Brisbane and Women's Hospital
OTHER_GOV
St Andrew's War Memorial Hospital
OTHER
Buderim Private Hospital
UNKNOWN
Queensland Centre for Gynaecological Cancer
OTHER_GOV