Clinical trial NCT00882791: Basal Cell Carcinoma Recurrence After Mohs Surgery
Official title: Basal Cell Carcinoma Recurrence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Keywords: Skin Cancer
Basal Cell
Mohs surgery
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-04-17
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Recurrence of BCC
timeFrame: either after 1 study visit (historical arm), or 3 years (prospective arm)
Secondary outcomes:
measure: Risk Factors for recurrence of BCC
timeFrame: either after 1 study visit (historical arm), or 3 years (prospective arm)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
city: Naperville
country: United States
facility: DuPage Medical Group Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1001/archderm.140.8.985.
citation: Robinson JK, Fisher SG. Recurrent basal cell carcinoma after incomplete resection. Arch Dermatol. 2000 Nov;136(11):1318-24. doi: 10.1001/archderm.136.11.1318.
citation: Dubin N, Kopf AW. Multivariate risk score for recurrence of cutaneous basal cell carcinomas. Arch Dermatol. 1983 May;119(5):373-7.