Basal Cell Carcinoma Recurrence After Mohs Surgery

Completed

• Conditions: Basal Cell Carcinoma

• Registration Number: NCT00882791
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-04-16
• Study First Submitted QC: 2009-04-16
• Study First Posted: 2009-04-17
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of BCC	either after 1 study visit (historical arm), or 3 years (prospective arm)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Northwestern University Feinberg School of Medicine, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States

DuPage Medical Group Dermatology; 🇺🇸 Naperville, Illinois, United States