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Clinical Trials/NCT00959491
NCT00959491
Unknown
Not Applicable

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

National Institute of Gastroenterology, Cuba1 site in 1 country160 target enrollmentOctober 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colonoscopy
Sponsor
National Institute of Gastroenterology, Cuba
Enrollment
160
Locations
1
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
November 2010
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
National Institute of Gastroenterology, Cuba

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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