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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

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ClinicalTrials.gov Identifier: NCT02296970
Recruitment Status : Active, not recruiting
First Posted : November 21, 2014
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy Patton, DO, University of Pittsburgh

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.

Condition or disease Intervention/treatment
Basal Cell Carcinoma Procedure: Deep shave removal using a blue surgical blade

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.

Study Type : Observational
Estimated Enrollment : 78 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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
Study Start Date : December 2014
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : December 2018

Intervention Details:
  • 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


Primary Outcome Measures :
  1. Measurement of clinical cure rate of deep shave removal in the treatment of BCC [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Percentage of deep shave removal BCC with clear margins [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients 18 or older with the clinical diagnosis of BCC
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296970


Locations
United States, Pennsylvania
Shadyside Place
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Timothy J Patton, DO University of Pittsburgh

Publications of Results:
Responsible Party: Timothy Patton, DO, Assistant Professor of Dermatology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02296970     History of Changes
Other Study ID Numbers: PRO14020682
First Posted: November 21, 2014    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Carcinoma
Recurrence
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Neoplasms, Basal Cell