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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by National Institute of Gastroenterology, Cuba.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Gastroenterology, Cuba
ClinicalTrials.gov Identifier:
NCT00959491
First received: August 13, 2009
Last updated: October 19, 2010
Last verified: October 2009
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Luis Calzadilla Bertot, National Institute of Gastroenterology
ClinicalTrials.gov Identifier: NCT00959491     History of Changes
Other Study ID Numbers: RH-9
Study First Received: August 13, 2009
Last Updated: October 19, 2010
Health Authority: Cuba: Scientific and Ethics Committee

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

ClinicalTrials.gov processed this record on August 21, 2014