Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

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
VA Office of Research and Development

1,668 total trials

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.

Similar trials for Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00847912's enrollment target sits among peer trials

954 2nd of 29 the highest of 29 other Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT06225596 · 956 participants · Phase 2

    Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

  • NCT04375033 · 952 participants · Phase 4

    A Study Comparing Oral Buprenorphine and Injectable Buprenorphine for the Treatment of Opioid Use Disorder

  • NCT06259669 · 958 participants

    Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population

  • NCT03784924 · 950 participants

    EDRN Prostate MRI Biomarker Study

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT00847912, the US trial registry maintained by the National Library of Medicine. NCT00847912 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.