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Clinical Trials/ACTRN12611000712909
ACTRN12611000712909
Recruiting
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 enrollmentJuly 11, 2011

Overview

Phase
未知
Intervention
Not specified
Conditions
High risk non melanoma skin cancer
Sponsor
Sydney Head and Neck Cancer Institute
Enrollment
30
Status
Recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 11, 2011
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sydney Head and Neck Cancer Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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