Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06264167
NA

NODE (groiN ultrasOunD cancEr)

Sponsor: Queensland Centre for Gynaecological Cancer

View on ClinicalTrials.gov

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

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.

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