Basal Cell Carcinoma Recurrence After Mohs Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00882791
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : September 17, 2012
Information provided by (Responsible Party):
Murad Alam, 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.

Condition or disease
Basal Cell Carcinoma

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 Type : Observational
Actual Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Basal Cell Carcinoma Recurrence
Study Start Date : May 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Historical Arm
266 cases of BCC treated with Mohs surgery approximately 2-5 years ago will be assessed for recurrence.
Prospective Arm
300 cases of BCC will be followed annually for 3 years after Mohs surgery to assess for recurrence.

Primary Outcome Measures :
  1. Recurrence of BCC [ Time Frame: either after 1 study visit (historical arm), or 3 years (prospective arm) ]

Secondary Outcome Measures :
  1. Risk Factors for recurrence of BCC [ Time Frame: either after 1 study visit (historical arm), or 3 years (prospective arm) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be selected from Northwestern University - Department of Dermatology, Chicago, IL and from DuPage Medical Group Dermatology, Naperville, IL.

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

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 identifier (NCT number): NCT00882791

United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
DuPage Medical Group Dermatology
Naperville, Illinois, United States, 60563
Sponsors and Collaborators
Northwestern University
Principal Investigator: Murad Alam, MD Northwestern University

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University Identifier: NCT00882791     History of Changes
Other Study ID Numbers: STU2538
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012

Keywords provided by Murad Alam, Northwestern University:
Skin Cancer
Basal Cell
Mohs surgery

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