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NCT00032344 · ClinicalTrials.gov registry record · Phase 3

Long-term Follow-up Study Designed to Evaluate the Relative Risk of Two Colonoscopy Schedules for Patients With Small Polyps

A Phase 3 study, sponsored by US Department of Veterans Affairs.

Completed
Registry status
Phase 3
Development phase
3,200
Enrollment target

NCT00032344 is a Phase 3 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 3,200 participants.

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The verdict

NCT00032344, a Phase 3 study, has completed, sponsored by US Department of Veterans Affairs.

COMPLETED
Registry status
Phase 3
Development phase
3,200 participants
Enrollment target

Study Summary

Colorectal cancer is a leading cause of cancer death in the United States. Mortality remains high because most colorectal cancers are detected after there has been regional or distant spread, precluding curative surgical resection. With this in mind, screening strategies have been recommended for asymptomatic individuals which hope to reduce mortality from colon cancer by detecting and removing premalignant adenomatous polyps or early malignant lesions. Screening of asymptomatic individuals over age 50 with sigmoidoscopy and fecal occult blood tests has been advocated by the American Cancer Society. However, current screening will identify only 50% of patients who have adenomatous polyps. More sensitive tests for polyp detection, like colonoscopy, are costly, require extensive resources and are unlikely to be used for screening large populations. Ideal screening would identify patients with the highest risk of cancer and target more sensitive screening tests at this population. The identification of low cost, easily collectible risk factors which can be used to target patients for the more sensitive screening tests is the primary purpose of this study. Since a major segment of the veteran population is over the age of 50, there will be a substantial impact in reduction of both mortality and morbidity due to colon cancer and attendant cost savings to the VA for treatment if such risk factors can be identified. Phase I is a cross-sectional study designed to identify risk factors for large (\>1 cm) adenomatous polyps. Approximately 3200 asymptomatic subjects (age 50-75) have completed risk factor assessment, medical and dietary histories, and have undergone complete colonoscopy examination. This will identify for comparison purposes a polyp-free control group and is the first large prospective study to include such a group. Data at colonoscopy will characterize the prevalence, size and distribution of adenomatous polyps. This will permit an assessment of sensitivity o

Interventions

  • PROCEDURE Colonoscopy

Trial Details

FieldValue
Enrollment Target 3,200 participants
Start Date 1993-10
Est. Completion 2007-02
Phase Phase 3

Sponsor

US Department of Veterans Affairs

632 total trials

What the Registry Record Tells You About NCT00032344

The ClinicalTrials.gov registry entry for NCT00032344 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 3,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Colonoscopy is the first listed.

NCT00032344 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00032344 about?

NCT00032344 is a clinical study titled "Long-term Follow-up Study Designed to Evaluate the Relative Risk of Two Colonoscopy Schedules for Patients With Small Polyps". Colorectal cancer is a leading cause of cancer death in the United States. Mortality remains high because most colorectal cancers are detected after there has been regional or distant spread, precluding curative surgical resection. With this in mind, screening strategies have been recommended for as...

What is the current status of trial NCT00032344?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,200 participants. The study started on 1993-10. Estimated completion is 2007-02.

What interventions are being tested in trial NCT00032344?

The interventions under investigation include: Colonoscopy (PROCEDURE).

Who is sponsoring clinical trial NCT00032344?

This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.