MedTrace Logo

NODE (groiN ultrasOunD cancEr)

NCT06264167 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Vulvar Cancer Stage Ib
  • Vulvar Cancer Stage II
  • Lymph Node Metastasis
  • Groin Node
  • Ultrasound 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.

Sponsors & Collaborators

  • Royal Brisbane and Women's Hospital

    collaborator OTHER_GOV

  • St Andrew's War Memorial Hospital

    collaborator OTHER

  • Buderim Private Hospital

    collaborator UNKNOWN

  • Queensland Centre for Gynaecological Cancer

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06264167 on ClinicalTrials.gov