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

Sponsor
Hamamatsu University (Other)
Overall Status
Unknown status
CT.gov ID
NCT00197405
Collaborator
(none)
400
Enrollment
1
Location
136
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Comparative Study of Fecal RNA Test With Immunochemical Fecal Occult Blood Test for Detecting Colorectal Cancer and Adenoma
    Study Start Date :
    Aug 1, 1999
    Anticipated Study Completion Date :
    Dec 1, 2010

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:

      • Clinical diagnosis of colorectal cancer or adenoma

      • Subjects with no abnormal findings of colon

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Hamamatsu University School of Medicine Hamamatsu Japan 431-3192

      Sponsors and Collaborators

      • Hamamatsu University

      Investigators

      • Study Chair: Shigeru Kanaoka, M.D.,

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00197405
      Other Study ID Numbers:
      • CRC-FRT-001
      First Posted:
      Sep 20, 2005
      Last Update Posted:
      Aug 4, 2009
      Last Verified:
      Aug 1, 2009
      Additional relevant MeSH terms:
      Colorectal Neoplasms
      Adenoma

      Study Results

      No Results Posted as of Aug 4, 2009