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NCT00847912 · ClinicalTrials.gov registry record · Phase 4
CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial
A Phase 4 study of Carcinoma and Carcinoma, Squamous Cell, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 4
- Development phase
- 954
- Enrollment target
- 13
- Study locations
NCT00847912: Completed Phase 4 study of Carcinoma and Carcinoma, Squamous Cell, sponsored by VA Office of Research and Development.
NCT00847912 is a Phase 4 study of Carcinoma and Carcinoma, Squamous Cell that has completed, run by VA Office of Research and Development. The registered enrollment target is 954 participants, above the 222-participant average among 29 other Carcinoma trials with a reported enrollment target (330% higher). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00847912, a Phase 4 study of Carcinoma and Carcinoma, Squamous Cell, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 954 participants
- Enrollment target
- 13
- Study locations
Study Summary
The main purpose of this study is to see if 5-fluorouracil (5-FU) skin cream can prevent the growth of new skin cancers on the face and ears. The cost of trying to prevent skin cancer will be compared to the usual cost of treating skin cancer. Participants are being asked to be a part of this study because the participants have been treated for two or more skin cancers within the past five (5) years. At least one of these cancers occurred on the face or ears. Having had two or more skins cancers in the past 5 years makes it likely that participants will develop additional skin cancers in the future. Exposure to ultraviolet radiation from the sun or artificial sources such as tanning beds is a major cause of basal cell and squamous cell carcinoma of the skin. Using lotions, creams, or gels that contain sunscreens can help protect the skin from premature aging and damage that may lead to skin cancer. The 5-FU skin cream used in this study is FDA-approved to treat some types of skin cancers and spots that might become skin cancer. However, 5-FU skin cream has never been studied to see if it can prevent skin cancer. This drug is not approved by the FDA for how it will be used in this study. In this study, one half of the patients will use the 5-FU cream and the other half will use a skin cream that looks identical to the 5-FU cream but does not have 5-FU or any other active drug in it. Approximately twelve VA medical centers will work together in this study. About one thousand (1000) patients will be in this study. The study is sponsored by the U.S. Department of Veterans Affairs Cooperative Studies Program.
Primary Outcome
Diagnosis of the first Primary Basil Cell Carcinoma (BCC) or primary Squamous Cell Carcinoma (SCC) on the face or ears that was removed surgically.
Conditions Studied
Interventions
- DRUG 5-fluorouracil
- DRUG Placebo, vehicle control
Study Locations (13)
California
- VA Palo Alto Health Care System, Palo Alto, CA - Palo Alto
- VA San Diego Healthcare System, San Diego, CA - San Diego
Florida
- Bay Pines VA Healthcare System, Pay Pines, FL - Bay Pines
- Miami VA Healthcare System, Miami, FL - Miami
Colorado
- VA Eastern Colorado Health Care System, Denver, CO - Denver
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur
Illinois
- Edward Hines Jr. VA Hospital, Hines, IL - Hines
Massachusetts
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA - Boston
Minnesota
- Minneapolis VA Health Care System, Minneapolis, MN - Minneapolis
North Carolina
- Durham VA Medical Center, Durham, NC - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 954 participants |
| Start Date | 2009-06-26 |
| Est. Completion | 2016-07-30 |
| Phase | Phase 4 |
What the finished NCT00847912 record still lists
NCT00847912 is an interventional study that assigns participants to a tested intervention. The registered 954 participants enrollment target is mid-sized for trials with a published cap, above the 222-participant average among 29 other Carcinoma trials with a reported enrollment target (330% higher).
The record links to 7 conditions, with Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which 5-fluorouracil is the first listed.
NCT00847912 lists 13 locations in 11 states (California, Florida, Colorado).
Frequently Asked Questions
What is clinical trial NCT00847912 about?
NCT00847912 is a clinical study titled "CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial". The main purpose of this study is to see if 5-fluorouracil (5-FU) skin cream can prevent the growth of new skin cancers on the face and ears. The cost of trying to prevent skin cancer will be compared to the usual cost of treating skin cancer. Participants are being asked to be a part of this study ...
What is the current status of trial NCT00847912?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 954 participants. The study started on 2009-06-26. Estimated completion is 2016-07-30.
What conditions does trial NCT00847912 study?
This clinical trial studies the following conditions: Carcinoma, Carcinoma, Squamous Cell, Skin Diseases, Skin Neoplasms, Neoplasms, Squamous Cell.
What interventions are being tested in trial NCT00847912?
The interventions under investigation include: 5-fluorouracil (DRUG), Placebo, vehicle control (DRUG).
Who is sponsoring clinical trial NCT00847912?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00847912 being conducted?
This trial has 13 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00847912's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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