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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by University of California, San Diego.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00533975
First received: September 20, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  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
Official Title: A Prospective Study of a New Immunochemical Fecal Occult Blood Test in U.S. Veteran Patients Undergoing Colonoscopy

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Estimated Enrollment: 500
Study Start Date: September 2007
Estimated Study Completion Date: December 2008
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533975

Contacts
Contact: Jeffrey K Lee, B.A. 510-847-1198 jklee@ucsd.edu

Locations
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.         
Sponsors and Collaborators
University of California, San Diego
Investigators
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 April 17, 2014