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COMPLETED Phase 4

CSP #562 - The VA Keratinocyte Carcinoma Chemoprevention Trial

NCT00847912 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 954 participants
Start Date 2009-06-26
Est. Completion 2016-07-30
Phase Phase 4

Sponsor

VA Office of Research and Development

1,863 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00847912

The ClinicalTrials.gov registry entry for NCT00847912 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 954 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00847912 reports 13 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00847912?

The interventions under investigation include: 5-fluorouracil (DRUG), Placebo, vehicle control (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00847912?

This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial