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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by National Institute of Gastroenterology, Cuba.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00959491
First Posted: August 14, 2009
Last Update Posted: October 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Gastroenterology, Cuba
  Purpose
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
Colonoscopy Occult Blood Immunologic Tests

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective Study of a New Immunological Fecal Occult Blood Test in Patients Referred for Colonoscopy

Resource links provided by NLM:


Further study details as provided by National Institute of Gastroenterology, Cuba:

Biospecimen Retention:   Samples Without DNA
One fecal sample

Estimated Enrollment: 160
Study Start Date: October 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Colonoscopy indication
All outpatients referred to colonoscopy according to inclusion criteria in the specified period time of one year .

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.
  Eligibility

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.
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
  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


Locations
Cuba
National Institute of Gastroenterology
Havana, Cuba, 10400
Sponsors and Collaborators
National Institute of Gastroenterology, Cuba
Investigators
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 Submitted: August 13, 2009
First Posted: August 14, 2009
Last Update Posted: October 20, 2010
Last Verified: October 2009

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


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