This trial is active, not recruiting.

Conditions colonoscopy, occult blood, immunologic tests
Sponsor National Institute of Gastroenterology, Cuba
Start date October 2009
End date October 2010
Trial size 160 participants
Trial identifier NCT00959491, RH-9


The purpose of the investigators study is to evaluate the diagnostic ability of a new immunological fecal occult blood test in Cuban patients undergoing colonoscopy .

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective
All outpatients referred to colonoscopy according to inclusion criteria in the specified period time of one year .

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients (men or women) that are >18 years of age referred to colonoscopy. Exclusion Criteria: - Visible rectal bleeding - Known diagnosis of inflammatory bowel disease - Hematuria - Menstruation at the time of obtaining a stool specimen - Patients taking medication such as non steroids anti inflammatory drugs and anticoagulants

Additional Information

Official title A Prospective Study of a New Immunological Fecal Occult Blood Test in Patients Referred for Colonoscopy
Principal investigator Luis C Bertot, MD
Description Colorectal cancer is a major cause of cancer deaths in many countries. Therefore, the importance of screening for the early detection of colorectal cancer is evident. Fecal occult blood screening is proving to be an effective tool for detecting premalignant adenomas and colon cancer since the guaiac-based test was introduced in the late 1960s. However, several immunochemical fecal occult blood tests (IFOBTs) have become commercially available and the majority of these have demonstrated equal or superior sensitivities and specificities than the guaiac-based tests. Therefore, IFOBTs are replacing guaiac based tests despite their higher costs.In this study we evaluate the diagnostic accuracy of a new IFOBT and compare with the findings on colonoscopy.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by National Institute of Gastroenterology, Cuba.