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

September 20, 2007 updated by: University of California, San Diego
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • Veteran Affairs Medical Center San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

September 20, 2007

First Submitted That Met QC Criteria

September 20, 2007

First Posted (Estimate)

September 24, 2007

Study Record Updates

Last Update Posted (Estimate)

September 24, 2007

Last Update Submitted That Met QC Criteria

September 20, 2007

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 071015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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