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A Prospective Study of a New Immunochemical Fecal Occult Blood Test in U.S. Veteran Patients Undergoing Colonoscopy

18 Years
Not Enrolling
Colon Cancer

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Trial Information

A Prospective Study of a New Immunochemical Fecal Occult Blood Test in U.S. Veteran Patients Undergoing Colonoscopy

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.

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

Type of Study:


Study Design:

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal, Time Perspective: Prospective

Principal Investigator

Samuel B Ho, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UCSD, VA San Diego


United States: Institutional Review Board

Study ID:




Start Date:

September 2007

Completion Date:

December 2008

Related Keywords:

  • Colon Cancer
  • Colon Cancer screening
  • immunofecal occult blood test
  • colonoscopy
  • diagnostic validity
  • Colonic Neoplasms



Veteran Affairs Medical Center San Diego San Diego, California  92161