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NCT00197405 Clinical Trial

Comparison of Fecal Ribonucleic Acid (RNA) Test With Fecal Occult Blood Test (FOBT) for Detecting Colorectal Cancer and Adenoma

Colorectal Cancer Clinical Trial

Official title:
Comparative Study of Fecal RNA Test With Immunochemical Fecal Occult Blood Test for Detecting Colorectal Cancer and Adenoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00197405
Other study ID # CRC-FRT-001
Secondary ID
Status Recruiting
Phase N/A
First received September 12, 2005
Last updated August 3, 2009
Start date August 1999
Est. completion date December 2010

Study information
Verified date August 2009
Source Hamamatsu University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial Summary

Colorectal cancer (CRC) is the second common cause of death in the Western world, and is very increasing in Japan. Fecal occult blood test (FOBT) is used routinely for CRC screening, which has been shown to reduce the incidence, morbidity, and mortality of CRC. However, there is a need to develop a novel method to improve sensitivity. The investigators reported that Fecal COX-2 assay, one of fecal RNA test, is potentially useful for colorectal cancer screening (Gastroenterology 127; 422-427, 2004). So the investigators planed to compare fecal RNA test with FOBT for detecting colorectal cancer and adenoma.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date December 2010
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of colorectal cancer or adenoma

- Subjects with no abnormal findings of colon

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Hamamatsu University School of Medicine Hamamatsu

Sponsors (1)
Lead Sponsor Collaborator
Hamamatsu University

Country where clinical trial is conducted

Japan, 

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