Cure Rates of Superficial Basal Cell Carcinom (BCC) Following 1 Versus 3 Cycles of Electrodessication and Curettage (ED&C)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Skin Cancer Foundation
Dermatology Foundation
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00994240
First received: October 9, 2009
Last updated: June 19, 2013
Last verified: June 2013
  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

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 2013 (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
Criteria

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
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: NCT00994240

Locations
United States, Wisconsin
University of Wisconsin-Madison, Department of Dermatology
Madison, Wisconsin, United States, 53715
Sponsors and Collaborators
University of Wisconsin, Madison
Skin Cancer Foundation
Dermatology Foundation
Investigators
Principal Investigator: Joyce Teng, MD University of Wisconsin, Madison
  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: June 19, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014