ACTRN12616000645459
Terminated
未知
Prospective collection of clinical data following sentinel node biopsy for vulval carcinoma in Australia and New Zealand
niversity Of Otago Christchurch0 sites316 target enrollmentMay 18, 2016
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Vulval carcinoma
- Sponsor
- niversity Of Otago Christchurch
- Enrollment
- 316
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •.1\.Able to give informed consent.
- •2\.Early vulval carcinoma confirmed histologically (unifocal, invasive squamous cell carcinoma less than 4cm in greatest dimension \- not including insitu component)
- •3\.Depth of invasion greater than 1mm
Exclusion Criteria
- •1\.Tumour involves urethra, anus or middle 1/3 of vagina.
- •2\.Reconstruction of the vulva using a flap has been performed with removal of the
- •primary lesion .
- •3\.Clinical evidence of groin node metastasis.(palpation, imaging , FNA)
- •4\.Prior history of SCC of the genital tract, anus, or lower body.
- •5\.Prior groin node dissection
Outcomes
Primary Outcomes
Not specified
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