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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Hamamatsu University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00197405
First Posted: September 20, 2005
Last Update Posted: August 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hamamatsu University
  Purpose
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
Colorectal Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hamamatsu University:

Biospecimen Retention:   Samples Without DNA
freces, biopsy tissue samples

Estimated Enrollment: 400
Study Start Date: August 1999
Estimated Study Completion Date: December 2010
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
outpatients and inpatients of hospitals, subjects of parimary care clinics
Criteria

Inclusion Criteria:

  • Clinical diagnosis of colorectal cancer or adenoma
  • Subjects with no abnormal findings of colon
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197405


Locations
Japan
Hamamatsu University School of Medicine Recruiting
Hamamatsu, Japan, 431-3192
Contact: Shigeru Kanaoka, M.D.    81-53-435-2261    kanaoka@hama-med.ac.jp   
Principal Investigator: Shigeru Kanaoka, M.D.         
Sponsors and Collaborators
Hamamatsu University
Investigators
Study Chair: Shigeru Kanaoka, M.D.
  More Information

Responsible Party: Shigeru Kanaoka, Hamamatsu University School of Medicine
ClinicalTrials.gov Identifier: NCT00197405     History of Changes
Other Study ID Numbers: CRC-FRT-001
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: August 4, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
Colorectal Neoplasms
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type