Clinical trial NCT00533975: A Prospective Study of a New Immunochemical Fecal Occult Blood Test in U.S. Veteran Patients Undergoing Colonoscopy
Official title: A Prospective Study of a New Immunochemical Fecal Occult Blood Test in U.S. Veteran Patients Undergoing Colonoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Keywords: Colon Cancer screening
immunofecal occult blood test
colonoscopy
diagnostic validity
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2007-09-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: 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.

Detailed description: 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 criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Veteran Affairs Medical Center San Diego
state: California
Study officials:
affiliation: UCSD, VA San Diego
name: Samuel B Ho, M.D.
role: PRINCIPAL_INVESTIGATOR
References: