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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00533975
• Other study ID #: 071015
• Status: Not yet recruiting
• Phase: N/A
• First received: September 20, 2007
• Last updated: September 20, 2007
• Start date: September 2007
• Est. completion date: December 2008

Study information

• Verified date: June 2007
• Source: University of California, San Diego
• Contact: Jeffrey K Lee, B.A.
• Phone: 510-847-1198
• Email: jklee[@]ucsd.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Colon Cancer

Locations

Country	Name	City	State
United States	Veteran Affairs Medical Center San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States,