Status:
COMPLETED
An Observational Study to Determine the Clinical Cure Rate of Therapeutic up Front Shave Removal of Basal Cell Carcinoma of the Skin With Long Term Follow up to Evaluate Recurrence
Lead Sponsor:
University of Pittsburgh
Conditions:
Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
Determine the effectiveness of a deep shave removal as a definitive treatment for basal cell carcinoma (BCC) without the need for a follow up surgical procedure.
Detailed Description
Basal cell carcinoma (BCC) is the most common skin cancer in the world, with approximately 3.5 million cases a year diagnosed in the United States. BCC are indolent and metastasis is extremely rare, o...
Eligibility Criteria
Inclusion
- Patients 18 years or older that are determined by an investigator to have a lesion that is highly likely to be a BCC, less than or equal to 1.0cm in largest diameter, based on clinical examination located in the trunk or extremities, proximal to the wrist and ankles
- Subject is able to give informed consent
- Subject is able to commit to 6 month follow up visit
Exclusion
- BCC \> 1cm in diameter on any one axis.
- Immunosuppressed patients
- Subjects with neutropenia
- Organ transplant patients
- Subjects with a life expectancy less than year
- Patients taking immunosuppressive medications, including prednisone at a dose of 10mg or greater with an expected duration greater than 4 weeks, azathioprine, mycophenolate mofetil, cyclosporine, oral Tacrolimus, any Tumor Necrosis Factor (TNF)-alpha inhibitor, ustekinumab, rituximab, or any other medication in the judgement of the investigator could results in clinically meaningful immunosuppression of the subject
- Basal cell carcinomas that have infiltrative or morpheaform characteristics based on clinical examination
- Subjects unable to provide informed consent
- Subjects unable to commit to 6 month follow up
Key Trial Info
Start Date :
December 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT02296970
Start Date
December 1 2014
End Date
December 31 2018
Last Update
April 5 2019
Active Locations (1)
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1
Shadyside Place
Pittsburgh, Pennsylvania, United States, 15232