Cure Rates of Superficial Basal Cell Carcinom (BCC) Following 1 Versus 3 Cycles of Electrodessication and Curettage (ED&C)
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Purpose
This is a prospective, randomized clinical trial conducted at the Unviersity of Wisconsin (UW) Dermatology Clinic located at 1 S. Park Street, Madison, WI 53715. There are no controls. Subjects meeting eligibility criteria are randomly divided into one of two treatment groups (ED&C x 1 cycle or ED&C x 3 cycles) using computer generated random numbers. One cycle of ED&C is defined according to standard technique currently employed. It involves scraping away the tumor with a curette (ring- shaped instrument) and then burning the curetted site with a small electric needle (electrodessication). During Visit 1, the surgical site is marked, local numbing medication is injected, and 1 or 3 cycles of ED&C is/are performed by board-certified dermatologists or a dermatology resident under the direct supervision of a board certified dermatologist. All follow-up visits (3, 6, 9, and 12 months after Visit 1) include skin evaluations by the physician who performed the ED&C. The lesion site is examined, measured, and photographed for clinical evidence of recurrence, as defined by a new lesion within the previously treated site. If there is evidence of possible tumor recurrence at the treated surgical site during Visit 2, 3, 4 or 5, then the lesion will be biopsied using a shave procedure.
| Condition | Intervention | Phase |
|---|---|---|
|
Superficial Basal Cell Carcinoma |
Procedure: Electrodessication & Curettage |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cure Rates of Superficial Basal Cell Carcinoma Following 1 Versus 3 Cycles of Electrodessication & Curettage: A Randomized Prospective Study |
- The primary goal of the study is to determine whether there is a difference in cure rates of superficial BCC following one cycle of ED&C versus three cycles of ED&C. [ Time Frame: base line, every 3 months until 12 month completion ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | May 2008 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: ED&C times 3 cycles |
Procedure: Electrodessication & Curettage
Electrodessication & Curettage 1 or 3 cycles
|
| Active Comparator: ED & C times 1 cycle |
Procedure: Electrodessication & Curettage
Electrodessication & Curettage 1 or 3 cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Untreated, biopsy proven superficial type basal cell carcinoma (BCC-S) on the trunk and/or extremities
- Age greater than 21
- Women with childbearing potential (including those who are pregnant/lactating)
- Able to provide written informed consent
Exclusion Criteria:
- Aggressive histology on initial biopsy (i.e. morpheaform, infiltrative, desmoplastic, or purely micronodular)
- Prior history of BCC or other skin cancer at the same location
- Lesion > 2 cm
- Patients with basal cell nevus syndrome
- Transplant patients
- Immunocompromised patients
- Recurrent BCC
- Greater than 2 BCC-S on the trunk and/or extremities
- Prisoners
- Allergy to lidocaine or epinephrine
Contacts and Locations| United States, Wisconsin | |
| University of Wisconsin-Madison, Department of Dermatology | Recruiting |
| Madison, Wisconsin, United States, 53715 | |
| Contact: Tisha Kawahara, MS 608-287-2620 | |
| Principal Investigator: Eric Berg, MD | |
| Sub-Investigator: Rosemarie Liu, MD | |
More Information
No publications provided
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00994240 History of Changes |
| Other Study ID Numbers: | H-2007-0252, PRMC_CO08303 |
| Study First Received: | October 9, 2009 |
| Last Updated: | November 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Basal Cell Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Basal Cell |
ClinicalTrials.gov processed this record on May 19, 2013