Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT06264167
Eligibility Criteria:
Inclusion Criteria:
* Women, over 18 years, with histologically confirmed SCC, adenocarcinoma or melanoma 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)
* Squamous cell carcinoma (SCC) of the vulva with depth of invasion ≤1 mm
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06264167
Study Brief:
Protocol Section:
NCT06264167