Feasibility of Groin Ultrasound to Predict Groin Lymph Node Involvement in Patients with Histologically Proven Vulvar Cancer
- Conditions
- Vulvar CancerCancer - Other cancer types
- Registration Number
- ACTRN12622000886785
- Lead Sponsor
- niversity of Queensland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 100
Females, over 18 years, with histologically confirmed squamous cell carcinoma (SCC), adenocarcinoma or melanoma of the vulva
- Undergo inguino-femoral lymphadenectomy /sentinel node biopsy according to local clinical practice management guidelines
- Signed written informed consent
- Negative serum pregnancy test less than or equal to 30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause.
- Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget’s disease)
- SCC of the vulva with depth of invasion less than or equal to 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method