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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Japan
  • Hamamatsu, Japan, 431-3192
    • Recruiting
    • Hamamatsu University School of Medicine
    • Contact: Shigeru Kanaoka, M.D.; Phone Number: 81-53-435-2261; Email: kanaoka@hama-med.ac.jp
    • Principal Investigator: Shigeru Kanaoka, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

outpatients and inpatients of hospitals, subjects of parimary care clinics

Description

Inclusion Criteria:

• Clinical diagnosis of colorectal cancer or adenoma
• Subjects with no abnormal findings of colon

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Collaborators and Investigators

• Sponsor: Hamamatsu University
• Investigators: Study Chair: Shigeru Kanaoka, M.D.

Study record dates

Study Major Dates

• Study Start: August 1, 1999
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): August 4, 2009
• Last Update Submitted That Met QC Criteria: August 3, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: CRC-FRT-001