Long-term Follow-up Study Designed to Evaluate the Relative Risk of Two Colonoscopy Schedules for Patients With Small Polyps
CSP #380 - Prospective Evaluation of Risk Factors for Large (> 1 CM) Colonic Adenomas in Asymptomatic Subjects
1 other identifier
interventional
3,200
1 country
13
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Oct 1993
Longer than P75 for phase_3 colorectal-cancer
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1993
CompletedFirst Submitted
Initial submission to the registry
March 18, 2002
CompletedFirst Posted
Study publicly available on registry
March 19, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedAugust 31, 2018
August 1, 2018
13.3 years
March 18, 2002
August 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Phase I: Risk factors include: family history; dietary; fat, fiber, calcium; alcohol history; tobacco use; physical activity; obesity; NSAID use; and, biomarkers: BRDU, PCNA
Cross-sectional
Secondary Outcomes (2)
Phase II: Colonoscopy outcomes to determine recurrence rates and compare surveillance strategies
5 years
Phase III: Medical outcomes including mortality. Colonoscopy outcomes in subgroup of polyp free patient at baseline to determine long term risk.
10 years
Study Arms (1)
1
OTHERPhase I - Cross-sectional; Phase II - 5 year follow-up; Phase III - 10 year follow-up
Interventions
Phase I - Cross-sectional; Phase II - 5 year follow-up; Phase III - 10 year follow-up
Eligibility Criteria
You may qualify if:
- Study Complete
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012, United States
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, 85723, United States
VA Medical Center, Long Beach
Long Beach, California, 90822, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290, United States
VA Medical Center, San Francisco
San Francisco, California, 94121, United States
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, 80220, United States
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000, United States
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417, United States
VA Medical Center, Kansas City MO
Kansas City, Missouri, 64128, United States
VA Medical Center, Durham
Durham, North Carolina, 27705, United States
VA Medical Center, Portland
Portland, Oregon, 97239-2964, United States
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216, United States
VA Medical & Regional Office Center, White River
White River Junction, Vermont, 05009-0001, United States
Related Publications (1)
Schreiner MA, Weiss DG, Lieberman DA. Proximal and large hyperplastic and nondysplastic serrated polyps detected by colonoscopy are associated with neoplasia. Gastroenterology. 2010 Nov;139(5):1497-502. doi: 10.1053/j.gastro.2010.06.074. Epub 2010 Jul 13.
PMID: 20633561RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
David Lieberman, MD
VA Medical Center, Portland
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
March 18, 2002
First Posted
March 19, 2002
Study Start
October 1, 1993
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
August 31, 2018
Record last verified: 2018-08