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A Prospective Study of a New Immunological Fecal Occult Blood Test

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00959491
Acronym
RLHV
Enrollment
160
Registered
2009-08-14
Start date
2009-10-31
Completion date
2010-11-30
Last updated
2010-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Immunologic Tests, Occult Blood

Keywords

Colonoscopy, Occult Blood, Fecal

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.

Interventions

None listed

Sponsors

National Institute of Gastroenterology, Cuba
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Countries

Cuba

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026