NCT02296970

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 78 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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, occurring in less than .003% of cases. However, due to the high prevalence of this tumor, significant health care resources are used in its diagnosis and treatment. Management of BCC in many instances includes clinical evaluation of the lesion, biopsy or sampling of the lesion to confirm the diagnosis, followed by definitive treatment at a later date through surgical excision or medical therapy. A clinical diagnosis of BCC can be made with a high degree of confidence based on clinical findings. The investigators propose that by performing a deep shave removal of the entire lesion with histologically negative margins, based upon clinical diagnosis, complete removal can be achieved without the need for follow up therapy. Deep shave removal at time of initial evaluation is performed in many instances. The investigators believe that doing a deep shave removal would substantially reduce the number of second procedures that need to be done, thereby reducing treatment costs and patients' need to return for an additional procedure. In doing a deep shave removal, clinically diagnosed BCC will be removed entirely with narrow 2-3 mm margins, the tissue specimen will then be sent to the pathologist to confirm that margins are clear. The investigators will consider treatment of the BCC to be complete at this point and will follow the patients clinically.

Conditions

• Basal Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Deep shave removal using a blue surgical blade	Removal of a skin lesion with 2mm margins and an adequate amount of tissue deeper than the clinical appearance of the lesion using a blue surgical blade

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-06-01
• Completion: 2018-12-31
• First posted: 2014-11-21
• Last updated: 2019-04-05

Locations

1 site across 1 country: United States