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A Prospective Study of a New Immunological Fecal Occult Blood Test (RLHV)

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ClinicalTrials.gov Identifier: NCT00959491
Recruitment Status : Unknown
Verified October 2009 by National Institute of Gastroenterology, Cuba.
Recruitment status was:  Active, not recruiting
First Posted : August 14, 2009
Last Update Posted : October 20, 2010
Information provided by:

Study Description
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 .

Condition or disease
Colonoscopy Occult Blood Immunologic Tests

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.

Study Design

Study Type : Observational
Estimated Enrollment : 160 participants
Time Perspective: Prospective
Official Title: A Prospective Study of a New Immunological Fecal Occult Blood Test in Patients Referred for Colonoscopy
Study Start Date : October 2009
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Colonoscopy indication
All outpatients referred to colonoscopy according to inclusion criteria in the specified period time of one year .

Outcome Measures

Biospecimen Retention:   Samples Without DNA
One fecal sample

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Residents of Havana City admitted at the investigation center.

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959491

National Institute of Gastroenterology
Havana, Cuba, 10400
Sponsors and Collaborators
National Institute of Gastroenterology, Cuba
Principal Investigator: Luis C Bertot, MD National Institute of Gastroenterology , Havana, Cuba
More Information

Responsible Party: Luis Calzadilla Bertot, National Institute of Gastroenterology
ClinicalTrials.gov Identifier: NCT00959491     History of Changes
Other Study ID Numbers: RH-9
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: October 20, 2010
Last Verified: October 2009

Keywords provided by National Institute of Gastroenterology, Cuba:
Occult Blood