MedDataX Logo

A Prospective Study of a New Immunological Fecal Occult Blood Test

NCT ID: NCT00959491

Last Updated: 2010-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonoscopy Occult Blood Immunologic Tests

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Colonoscopy indication

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Gastroenterology, Cuba

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

National Institute of Gastroenterology

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Luis C Bertot, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Gastroenterology , Havana, Cuba

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Institute of Gastroenterology

Havana, La Habana, Cuba

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Cuba

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RH-9

Identifier Type: -

Identifier Source: org_study_id