A prospective audit of sentinel node biopsy for vulval carcinoma in Australia and New Zealand
Not Applicable
- Conditions
- Vulval carcinomaCancer - Other cancer types
- Registration Number
- ACTRN12616000645459
- Lead Sponsor
- niversity Of Otago Christchurch
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- Female
- Target Recruitment
- 316
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence in a groin with negative sentinel node as assessed clinically and entered on CRF[ at the time of recurrence and/or 24 months after surgery.]
- Secondary Outcome Measures
Name Time Method ode positivity rate as assessed and entered on CRF[ At time of sentinel node procedure and surgery];Disease recurrence at other sites as assessed clinically and entered on CRF[ At time of recurrence and/or at 3, 12, 24, 36, 48, and 60 months after surgery ];number of sentinel nodes detected using gamma-ray probe[ at the beginning of the surgical procedure];Morbitity as assessed clinically and entered on CRF[ At 3, 12, 24, 36, 48, and 60 months after surgery];length of Hospital stay after surgery[ at 3 months and entered on CRF];Utility of immunohistochemistry stains entered onto CRF[ At final data analysis ]