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Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC

Primary Purpose

Superficial Basal Cell Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrodessication & Curettage
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Superficial Basal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin-Madison, Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ED&C times 3 cycles

ED & C times 1 cycle

Arm Description

Outcomes

Primary Outcome Measures

Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.
Clinical evidence of BCC recurrence post treatment

Secondary Outcome Measures

Full Information

First Posted
October 9, 2009
Last Updated
February 25, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
Skin Cancer Foundation, Dermatology Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00994240
Brief Title
Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC
Official Title
Cure Rates of Superficial Basal Cell Carcinoma Following 1 Versus 3 Cycles of Electrodessication & Curettage: A Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
slow enrollment, lack of funding
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Skin Cancer Foundation, Dermatology Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Basal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ED&C times 3 cycles
Arm Type
Active Comparator
Arm Title
ED & C times 1 cycle
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Electrodessication & Curettage
Intervention Description
Electrodessication & Curettage 1 or 3 cycles
Primary Outcome Measure Information:
Title
Difference in Cure Rates of Superficial BCC Following One Cycle of ED&C Versus Three Cycles of ED&C.
Description
Clinical evidence of BCC recurrence post treatment
Time Frame
base line, every 3 months until 12 month completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Berg, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Madison, Department of Dermatology
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

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Cure Rates of Superficial Basal Cell Carcinoma (BCC) EDC

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