Actively Recruiting
NODE (groiN ultrasOunD cancEr)
Led by Queensland Centre for Gynaecological Cancer · Updated on 2026-02-20
30
Participants Needed
5
Research Sites
182 weeks
Total Duration
On this page
Sponsors
Q
Queensland Centre for Gynaecological Cancer
Lead Sponsor
R
Royal Brisbane and Women's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
NODE (groiN ultrasOunD cancEr)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women over 18 years with confirmed squamous cell carcinoma or adenocarcinoma of the vulva
- Clinically Stage I or II vulvar cancer without signs of spread on CT scans of pelvis, abdomen, and chest
- Suitable for surgical groin node removal according to local guidelines
- Able to provide signed informed consent
- Negative pregnancy test within 30 days before surgery for pre-menopausal women and women less than 2 years post-menopause
- Lives within 40 km of a medical imaging center (special approval possible)
You will not qualify if you...
- Women with non-invasive vulvar conditions such as non-invasive non-mammary Paget's disease
- Evidence of regional or distant metastatic disease on clinical exam or imaging
- Serious systemic illnesses not compatible with study participation
- Other cancers diagnosed within 5 years except treated keratinocyte skin cancers or ductal carcinoma in situ
- Life expectancy of 6 months or less
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
St Andrew's War Memorial Hospital
Brisbane, Queensland, Australia, 4000
Actively Recruiting
2
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Actively Recruiting
3
The Wesley Hospital
Brisbane, Queensland, Australia, 4066
Not Yet Recruiting
4
Buderim Private Hospital
Sunshine Coast, Queensland, Australia, 4556
Actively Recruiting
5
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Not Yet Recruiting
Research Team
S
Sara Baniahmadi
CONTACT
B
Brianna Armstrong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here