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Clinical Trials/NCT00882791
NCT00882791
Completed
Not Applicable

Basal Cell Carcinoma Recurrence

Northwestern University2 sites in 1 country115 target enrollmentMay 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Basal Cell Carcinoma
Sponsor
Northwestern University
Enrollment
115
Locations
2
Primary Endpoint
Recurrence of BCC
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Basal cell carcinoma (BCC) is the most common skin cancer in the US and can cause significant adverse effects.

Mohs micrographic surgery, the treatment of choice for higher risk BCC, allows for removal of lesions with preservation of healthy tissue. Although the BCC recurrence rate post Mohs surgery is estimated at 1-2%, recent data is lacking to validate this historical measurement.

Our purpose is to determine the current recurrence rate of BCC after Mohs surgery.

Detailed Description

Basal cell carcinoma (BCC) is the most common nonmelanoma skin cancer in the United States, affecting nearly one million of all Americans. While BCC is rarely mortal, it has significant associated physical, psychological, and monetary costs to patients such as disfigurement and sensory loss. Individuals who have been diagnosed with at least one BCC lesion are likely to be diagnosed with more in the future. Treatment of these lesions and recurrent physician appointments can be a great inconvenience to patients, resulting in expenses to patients and loss of work and family time. The Mohs surgery technique is associated with a low recurrence rate for BCC and is preferred for higher risk tumors and for tumors in cosmetically sensitive sites on the head and neck. While recurrence rates of BCC post Mohs are 1-2% for primary basal cells, recent data is not available to validate this historical assessment. Currently, comprehensive rates of recurrence are not available because a national registry of recurrence rates for BCC and squamous cell carcinoma (SCC) does not exist. The purpose of this study is to both historically and prospectively assess current basal cell carcinoma recurrence rates in patients undergoing Mohs micrographic surgery.

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
May 2009
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Murad Alam

Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation

Northwestern University

Eligibility Criteria

Inclusion Criteria

  • Subjects with BCC lesions on the head, neck, genitalia, hands, or feet
  • Subjects who have undergone Mohs micrographic surgery for BCC on or before December 31, 2006
  • Subjects with a medical record at the respective site
  • Subjects in a stable health condition, as determined by the principle investigator

Exclusion Criteria

  • Subjects with basal cell nevus syndrome
  • Subjects with lesions only in areas other than the head, neck, genitalia,
  • hands and feet
  • Subjects who have not followed up through the Department of Dermatology
  • Subjects with recurrent BCC lesions diagnosed on or prior to the recorded date of Mohs surgery

Outcomes

Primary Outcomes

Recurrence of BCC

Time Frame: either after 1 study visit (historical arm), or 3 years (prospective arm)

Secondary Outcomes

  • Risk Factors for recurrence of BCC(either after 1 study visit (historical arm), or 3 years (prospective arm))

Study Sites (2)

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