ACTRN12622000886785Recruiting未知
Feasibility of Groin Ultrasound to Predict Groin Lymph Node Involvement in Patients with Histologically Proven Vulvar Cancer
niversity of Queensland0 sites100 target enrollmentStarted: June 22, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Diagnosis
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •- 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.
Investigators
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