Basal Cell Carcinoma Recurrence After Mohs Surgery

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00882791
• Collaborator: (none)
• Enrollment: 115
• Locations: 2
• Duration (Months): 12
• Patients Per Site: 57.5
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 115 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Basal Cell Carcinoma Recurrence
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Recurrence of BCC [either after 1 study visit (historical arm), or 3 years (prospective arm)]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois	United States	60611
2	DuPage Medical Group Dermatology	Naperville	Illinois	United States	60563

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Dubin N, Kopf AW. Multivariate risk score for recurrence of cutaneous basal cell carcinomas. Arch Dermatol. 1983 May;119(5):373-7.
• Mehrany K, Weenig RH, Pittelkow MR, Roenigk RK, Otley CC. High recurrence rates of Basal cell carcinoma after mohs surgery in patients with chronic lymphocytic leukemia. Arch Dermatol. 2004 Aug;140(8):985-8.
• Robinson JK, Fisher SG. Recurrent basal cell carcinoma after incomplete resection. Arch Dermatol. 2000 Nov;136(11):1318-24.

• Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University
• ClinicalTrials.gov Identifier: NCT00882791
• Other Study ID Numbers: STU2538
• First Posted: Apr 17, 2009
• Last Update Posted: Dec 2, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by Murad Alam, Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation, Northwestern University: Skin Cancer; Basal Cell; Mohs surgery
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Basal Cell; Recurrence

Study Results

No Results Posted as of Dec 2, 2021