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

National Institute of Gastroenterology, Cuba

Status: Unknown

Conditions: Occult Blood; Colonoscopy; Immunologic Tests

Study type: Observational

Funder types: Other

Identifiers

NCT00959491

RH-9

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

160 participants in 1 patient group

Colonoscopy indication

Description:

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