Basal Cell Carcinoma Recurrence After Mohs Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00882791
First received: April 16, 2009
Last updated: September 14, 2012
Last verified: September 2012
  Purpose

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
Basal Cell Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Basal Cell Carcinoma Recurrence

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Recurrence of BCC [ Time Frame: either after 1 study visit (historical arm), or 3 years (prospective arm) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Risk Factors for recurrence of BCC [ Time Frame: either after 1 study visit (historical arm), or 3 years (prospective arm) ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: May 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00882791

Locations
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
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

Publications:
Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT00882791     History of Changes
Other Study ID Numbers: STU2538
Study First Received: April 16, 2009
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 29, 2014