A Prospective Study of a New Immunochemical Fecal Occult Blood Test in U.S. Veteran Patients Undergoing Colonoscopy
Recruitment status was Not yet recruiting
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Purpose
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 |
|---|
|
Colon Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Longitudinal Time Perspective: Prospective |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients (men or women) that are >18 years of age undergoing colonoscopy for a variety of indications (bleeding, diarrhea, weight loss, anemia, abdominal pain, etc)
Exclusion Criteria:
- concurrent hospitalization
- visible rectal bleeding
- known diagnosis of inflammatory bowel disease
- hematuria
- menstruation at the time of obtaining a stool specimen and performing the tests
- inability to prepare the 3 different IFOBT or 3 different FOBT kits
Contacts and Locations| Contact: Jeffrey K Lee, B.A. | 510-847-1198 | jklee@ucsd.edu |
| United States, California | |
| Veteran Affairs Medical Center San Diego | Not yet recruiting |
| San Diego, California, United States, 92161 | |
| Principal Investigator: Samuel B Ho, M.D. | |
| Principal Investigator: | Samuel B Ho, M.D. | UCSD, VA San Diego |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00533975 History of Changes |
| Other Study ID Numbers: | 071015 |
| Study First Received: | September 20, 2007 |
| Last Updated: | September 20, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Diego:
|
Colon Cancer screening immunofecal occult blood test colonoscopy diagnostic validity |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013