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Sponsors and Collaborators: |
Department of Veterans Affairs Central Lab-Tucson, AZ |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00032344 |
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 of sigmoidoscopy in this population. In addition, tissue from normal rectal mucosa will be analyzed for evidence of cell proliferation activity. The primary focus of Phase I is a risk factor analysis. A multivariate analysis will be performed to determine the relationship of historical and environmental factors as well as cell proliferation activity with the presence of adenomatous polyps. A cohort consisting of a subgroup of polyp patients (large and small) and matched polyp-free controls will be tracked longitudinally to determine polyp occurrence/recurrence rates.
Phase II of the study is a long-term follow-up study designed to evaluate the relative risk of two repeat colonoscopies.
Phase III is an extension in follow-up of an additional five years, a total of ten years in all, to include all study patients. The primary focus will be on documenting long-term mortality and medical outcomes as well as occurrence/reoccurrence of neoplasia with special emphasis on ten-year cancer rates.
Condition | Intervention | Phase |
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Colorectal Cancer |
Procedure: Colonoscopy |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | CSP #380 - Prospective Evaluation of Risk Factors for Large (> 1 CM) Colonic Adenomas in Asymptomatic Subjects |
Estimated Enrollment: | 3000 |
Study Start Date: | October 1993 |
Study Completion Date: | February 2007 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Phase 1 - Cross-sectional; Phase 2 - 5 year follow-up; Phase 3 - 10 year follow-up
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Procedure: Colonoscopy
Phase 1 - Cross-sectional; Phase 2 - 5 year follow-up; Phase 3 - 10 year follow-up
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Ages Eligible for Study: | 50 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Carl T. Hayden VA Medical Center | |
Phoenix, Arizona, United States, 85012 | |
Southern Arizona VA Health Care System, Tucson | |
Tucson, Arizona, United States, 85723 | |
Southern Arizona VA Health Care System, Tucson | |
Tucson, Arizona, United States, 85723 | |
United States, California | |
VA Medical Center, Long Beach | |
Long Beach, California, United States, 90822 | |
VA Palo Alto Health Care System | |
Palo Alto, California, United States, 94304-1290 | |
VA Medical Center, San Francisco | |
San Francisco, California, United States, 94121 | |
United States, Colorado | |
VA Eastern Colorado Health Care System, Denver | |
Denver, Colorado, United States, 80220 | |
United States, Illinois | |
Edward Hines, Jr. VA Hospital | |
Hines, Illinois, United States, 60141-5000 | |
Edward Hines, Jr. VA Hospital | |
Hines, Illinois, United States, 60141-5000 | |
United States, Minnesota | |
VA Medical Center, Minneapolis | |
Minneapolis, Minnesota, United States, 55417 | |
VA Medical Center, Minneapolis | |
Minneapolis, Minnesota, United States, 55417 | |
United States, Missouri | |
VA Medical Center, Kansas City MO | |
Kansas City, Missouri, United States, 64128 | |
United States, North Carolina | |
VA Medical Center, Durham | |
Durham, North Carolina, United States, 27705 | |
United States, Oregon | |
VA Medical Center, Portland | |
Portland, Oregon, United States, 97201 | |
United States, Texas | |
VA North Texas Health Care System, Dallas | |
Dallas, Texas, United States, 75216 | |
United States, Vermont | |
VA Medical & Regional Office Center, White River | |
White River Junction, Vermont, United States, 05009-0001 |
Study Chair: | David Lieberman, MD | VA Medical Center, Portland |
Responsible Party: | Department of Veterans Affairs ( Lieberman, David - Study Chair ) |
Study ID Numbers: | 380 |
Study First Received: | March 18, 2002 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00032344 |
Health Authority: | United States: Federal Government |
large (>1 cm) adenomas |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms Polyps |
Intestinal Diseases Rectal Diseases Adenoma Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site |