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Sponsored by: |
University of California, San Diego |
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Information provided by: | University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT00533975 |
The purpose of our study is to evaluate the diagnostic validity of a new immunofecal occult blood test (IFOBT) (Teco Diagnostics) in U.S. veterans and to compare it with the guaiac based FOBT.
Condition |
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Colon Cancer |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
Official Title: | A Prospective Study of a New Immunochemical Fecal Occult Blood Test in U.S. Veteran Patients Undergoing Colonoscopy |
Estimated Enrollment: | 500 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2008 |
Colorectal cancer (CRC) is the third most common cancer in men and women in the United States with an estimated 147,000 new cases and more than 56,000 deaths each year. Early detection of colon cancer and removal of precancerous adenomatous polyps have been shown to reduce its morbidity, mortality and incidence. There are several recommended CRC screening tests, including fecal occult blood test (FOBT), flexible sigmoidoscopy, air-contrast barium enema, and colonoscopy. In the VA, FOBT is the predominant screening test for CRC. Numerous randomized controlled trials have established the efficacy of FOBT in CRC screening. Its advantages include privacy, noninvasiveness, and cost-effectiveness. Use of guaiac-based testing, however, is hampered by low patient compliance, sensitivity, specificity, and positive predictive value. The poor patient compliance, and low specificity and positive predictive value, may be related to the testing procedure. For example, dietary and medication restrictions are recommended to decrease false-negative and false-positive tests. Such restrictions may impede patient compliance. Recently, several studies have evaluated the effectiveness immunochemical-based testing as a potential alternative, with reportedly better compliance, sensitivity, and specificity than guaiac-based tests. The purpose of our study is to evaluate the diagnostic validity of a new IFOBT (Teco Diagnostics) in U.S. veterans and to compare it with the guaiac based FOBT.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeffrey K Lee, B.A. | 510-847-1198 | jklee@ucsd.edu |
United States, California | |
Veteran Affairs Medical Center San Diego | |
San Diego, California, United States, 92161 |
Principal Investigator: | Samuel B Ho, M.D. | UCSD, VA San Diego |
Study ID Numbers: | 071015 |
Study First Received: | September 20, 2007 |
Last Updated: | September 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00533975 |
Health Authority: | United States: Institutional Review Board |
Colon Cancer screening immunofecal occult blood test colonoscopy diagnostic validity |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Colonic Neoplasms Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site |