| NCT ID | NCT06264167 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queensland Centre for Gynaecological Cancer |
| Condition | Vulvar Cancer Stage Ib |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-07-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Women, over 18 years, with histologically confirmed SCC or adenocarcinoma of the vulva * Clinically stage I or II on medical imaging (CT scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease * Participant must be suitable to undergo IFL/SNB according to local clinical practice management guidelines * Signed written informed consent * Negative serum pregnancy test ≤ 30 days of surgery in pre-menopausal women and women \< 2 years after the onset of menopause * Patient lives within 40 km of a medical diagnostic imaging centre (site investigator approval required for special circumstances) Exclusion Criteria: * Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease) * Clinical or medical imaging evidence of regional and/or distant metastatic disease * Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) * Other prior malignancies \<5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ * Estimated life expectancy of ≤6 months
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06264167 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Vulvar Cancer Stage Ib. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06264167 currently recruiting?
Yes, NCT06264167 is actively recruiting participants. Contact the research team at s.baniahmadi@uq.edu.au for enrollment information.
Where is the NCT06264167 trial being conducted?
This trial is being conducted at Brisbane, Australia, Brisbane, Australia, Brisbane, Australia, Sunshine Coast, Australia and 1 additional location.
Who is sponsoring the NCT06264167 clinical trial?
NCT06264167 is sponsored by Queensland Centre for Gynaecological Cancer. The trial plans to enroll 30 participants.
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