ACTRN12611000712909Recruiting未知
A non-randomised pilot study to assess feasibility of sentinel lymph node biopsy (SLNB) for patients with high risk clinicopathologic features of cutaneous squamous cell carcinoma.
Sydney Head and Neck Cancer Institute0 sites30 target enrollmentStarted: July 11, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
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
- All
Inclusion Criteria
- •Participants must be able to give fully informed consent and have non melanoma skin cancer with any of the following clinicopathologic risk factors:
- •-size > 2cm -invasion into subcutaneous fat or tumour thickness > 5mm -poorly differentiated phenotype
- •-perineural invasion
- •-lymphovascular invasion
- •-local recurrence
- •-location of lesion on lip or ear
- •-immunocomprimised host (post organ transplant, chemotherapy)
- •-carcinoma developing in pre-existing scar
Exclusion Criteria
- •Subjects meeting any of the following criteria will be excluded from participation:
- •-Clinical evidence of distant metastases
- •-previous surgery that is believed to have altered the local lymphatic drainage since emergence of lesion
- •-allergy to patent blue dye or radiocolloid
- •-inability to complete 5 years of follow up
- •-Participation in concurrent experimental protocols or alternative therapies that might confound the analysis of this trial. Adjuvant therapy protocols after recurrence are acceptable.
- •-significant cognitive or psychiatric disorder (inability to understand informed consent)
- •-pregnancy/lactation
Investigators
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