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

NCT02296970 | Completed DMC

• 1 other identifier: PRO14020682
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Measurement of clinical cure rate of deep shave removal in the treatment of BCC

  6 months

Secondary Outcomes (1)

• Percentage of deep shave removal BCC with clear margins

  6 months

Interventions

Deep shave removal using a blue surgical blade PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 or older with the clinical diagnosis of BCC

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Shadyside Place

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (2)

• Ahnlide I, Bjellerup M. Accuracy of clinical skin tumour diagnosis in a dermatological setting. Acta Derm Venereol. 2013 May;93(3):305-8. doi: 10.2340/00015555-1560.

  PMID: 23538779 RESULT

• Ek EW, Giorlando F, Su SY, Dieu T. Clinical diagnosis of skin tumours: how good are we? ANZ J Surg. 2005 Jun;75(6):415-20. doi: 10.1111/j.1445-2197.2005.03394.x.

  PMID: 15943729 RESULT

MeSH Terms

Conditions

Carcinoma, Basal Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Timothy J Patton, DO

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 21, 2014
• Study Start: December 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 31, 2018
• Last Updated: April 5, 2019

Record last verified: 2019-04

Locations

US (1)