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Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC

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ClinicalTrials.gov Identifier: NCT00994240
Recruitment Status : Terminated (slow enrollment, lack of funding)
First Posted : October 14, 2009
Results First Posted : February 27, 2015
Last Update Posted : February 27, 2015
Sponsor:
Collaborators:
Skin Cancer Foundation
Dermatology Foundation
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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 or disease Intervention/treatment Phase
Superficial Basal Cell Carcinoma Procedure: Electrodessication & Curettage Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2008
Actual Primary Completion Date : August 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    Clinical evidence of BCC recurrence post treatment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Eric Berg, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00994240     History of Changes
Other Study ID Numbers: H-2007-0252
PRMC_CO08303 ( Other Identifier: University of Wisconsin Carbone Cancer Center )
First Posted: October 14, 2009    Key Record Dates
Results First Posted: February 27, 2015
Last Update Posted: February 27, 2015
Last Verified: February 2015

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