VA Cooperative Studies Program (CSP)

Investigator Access

What's Available

Research data

Available Documentation 

Contact Lauren.Harris2@va.gov

Dates Data are Available 

Upon completion of study objectives

Access Criteria

Investigators associated with VA or non-VA nonprofit, academic, or research institutions may submit a Research Resource Request form to Lauren.Harris2@va.gov. Investigators may be asked to provide further documentation such as a study proposal.

All requests are reviewed for scientific and ethical merit. Access is contingent upon approval by the requestor’s Institutional Review Board (IRB) and, if applicable, a VA Research and Development (R&D) Committee. To gain access, requestors must sign a VA data use agreement. Requestors must be fully compliant with VA data security, privacy, and human subjects requirements.

Study Characteristics

Objective

Determine whether 5-fluorouracil skin cream can prevent the growth of new skin cancers on the face and ears in veterans at high risk for skin cancers

Era of Service

All

Population

Veterans with a history of two or more keratinocyte carcinomas (skin cancers), with at least one on the face or ears (median age 70 years, 98% male, 99% White)

Study Design

Randomized controlled trial with quadruple blinding

Intervention 

• 5-fluorouracil 5% topical cream and "Cool-down" period with triamcinolone 0.1% cream if 5-FU cream is not well tolerated
• Placebo topical cream

Time Period

May 2009 - September 2011

Setting

National

N

932 participants

Response Rate

97.7% (932 of 954 initially enrolled)

Recruitment Methods

Two recruitment strategies were employed:

• Site coordinators reviewed medical records of patients scheduled for Dermatology Clinic appointments and assessed their electronic medical records for eligibility. The Site Investigator approached potentially eligible patients to speak about the trial. Interested patients were given a more detailed overview of the trial and consent for participation was obtained.
• Request a comprehensive query of all patients who may have had two or more skin cancers in the prior five years was requested of each medical center. Study Coordinators mailed a recruitment letter to those potential participants and followed up with a phone call within two weeks.

Compensation

$20 - 40 per study visit to cover cost of gas and travel expenses

Data Collected

• Time to first occurrence of a surgically treated primary keratinocyte carcinoma
• Histopathologic specimens
• Photographs to document reactions to skin cream
• Self-reported symptoms/adverse effects of skin cream

Data Collection Methods

• Assessment by dermatologist
• Nurse interview (in person and by phone)
• Review of medical record
• Questionnaires

Funding Source

VA Cooperative Studies Program (CSP)

Investigator

Martin A. Weinstock

Contact

Lauren.Harris2@va.gov

Selected Publications

Weinstock MA, Thwin SS, Siegel JA, Marcolivio K, Means AD, Leader NF, Shaw FM, Hogan D, Eilers D, Swetter SM, Chen SC, Jacob SE, Warshaw EM, Stricklin GP, Dellavalle RP, Sidhu-Malik N, Konnikov N, Werth VP, Keri JE, Robinson-Bostom L, Ringer RJ, Lew RA, Ferguson R, DiGiovanna JJ, Huang GD; Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial (VAKCC) Group. Chemoprevention of Basal and Squamous Cell Carcinoma With a Single Course of Fluorouracil, 5%, Cream: A Randomized Clinical Trial. JAMA Dermatol. 2018 Feb 1;154(2):167-174.

Siegel JA, Chren MM, Weinstock MA; Department of Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial Group. Correlates of skin-related quality of life (QoL) in those with multiple keratinocyte carcinomas (KCs): A cross-sectional study. J Am Acad Dermatol. 2016 Sep;75(3):639-642.

Yoon J, Phibbs CS, Chow A, Pomerantz H, Weinstock MA. Costs of Keratinocyte Carcinoma (Nonmelanoma Skin Cancer) and Actinic Keratosis Treatment in the Veterans Health Administration. Dermatol Surg. 2016 Sep;42(9):1041-7.

Korgavkar K, Lee KC, Weinstock MA; Veterans Affairs Keratinocyte Carcinoma Chemoprevention (VAKCC) Trial Group. Effect of Topical Fluorouracil Cream on Photodamage: Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2017 Nov 1;153(11):1142-1146.

More Information

ClinicalTrials.gov Identifier: NCT00847912
Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)