BridgeMD
New treatment option for Vulvar Cancer Stage Ib
Official title NODE (groiN ultrasOunD cancEr)
ClinicalTrials.gov ID: NCT06264167
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brisbane, Queensland, Australia
- Sunshine Coast, Queensland, Australia
- Adelaide, South Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brisbane, Queensland, Australia; Sunshine Coast, Queensland, Australia; Adelaide, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.