NCT00959491

A Prospective Study of a New Immunological Fecal Occult Blood Test

A Prospective Study of a New Immunological Fecal Occult Blood Test in Patients Referred for Colonoscopy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: National Institute of Gastroenterology, Cuba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colonoscopy
• Occult Blood
• Immunologic Tests

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-10-01
• Completion: 2010-11-01
• First posted: 2009-08-14
• Last updated: 2010-10-20

Locations

1 site across 1 country: Cuba