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NCT00959491 Clinical Trial

A Prospective Study of a New Immunological Fecal Occult Blood Test

Colonoscopy Clinical Trial

— RLHV  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00959491
Other study ID # RH-9
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 13, 2009
Last updated October 19, 2010
Start date October 2009
Est. completion date November 2010

Study information
Verified date October 2009
Source National Institute of Gastroenterology, Cuba
Contact n/a
Is FDA regulated No
Health authority Cuba: Scientific and Ethics Committee
Study type Observational

Clinical Trial 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 .

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 information / eligibility
Status Active, not recruiting
Enrollment 160
Est. completion date November 2010
Est. primary completion date October 2010
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 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Cuba National Institute of Gastroenterology Havana

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Gastroenterology, Cuba

Country where clinical trial is conducted

Cuba, 

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