NODE (groiN ultrasOunD cancEr)

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2028

Conditions
Vulvar Cancer Stage IbVulvar Cancer Stage IILymph Node MetastasisGroin NodeUltrasound Therapy; Complications
Interventions
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.

Trial Locations (3)

4000

RECRUITING

St Andrew's War Memorial Hospital, Brisbane

4029

RECRUITING

Royal Brisbane and Women's Hospital, Brisbane

4556

RECRUITING

Buderim Private Hospital, Sunshine Coast

All Listed Sponsors
collaborator

Royal Brisbane and Women's Hospital

OTHER_GOV

collaborator

St Andrew's War Memorial Hospital

OTHER

collaborator

Buderim Private Hospital

UNKNOWN

lead

Queensland Centre for Gynaecological Cancer

OTHER_GOV