A Prospective Study of a New Immunological Fecal Occult Blood Test
- Conditions
- Occult BloodColonoscopyImmunologic Tests
- Registration Number
- NCT00959491
- Lead Sponsor
- National Institute of Gastroenterology, Cuba
- Brief Summary
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 .
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- Patients (men or women) that are >18 years of age referred to colonoscopy.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institute of Gastroenterology
🇨🇺Havana, Cuba