RecruitingNot ApplicableNCT06264167

NODE (groiN ultrasOunD cancEr)

Randomised Feasibility Study of Groin Ultrasound Surveillance to De-Escalate Surgical Intervention in Women With Vulvar Cancer

Sponsor

Queensland Centre for Gynaecological Cancer

Enrollment

30 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Lymph Node Metastasis Ultrasound Therapy; Complications Vulvar Cancer Stage Ib Vulvar Cancer Stage II Groin Node

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether ultrasound imaging of groin lymph nodes can help predict cancer spread in women with vulvar cancer, potentially reducing the need for more invasive lymph node removal surgery. **You may be eligible if...** - You are a woman over 18 years old - You have been diagnosed with squamous cell carcinoma or adenocarcinoma of the vulva - Your cancer is at an early stage (Stage I or II) with no signs of spread to nearby lymph nodes or distant organs - You are suitable for standard lymph node procedures (sentinel node biopsy or inguinal lymph node dissection) - You live within 40 km of a medical imaging centre **You may NOT be eligible if...** - You have non-invasive vulvar conditions only - There is already clinical or imaging evidence of lymph node spread - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTHigh-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.