NCT00197405

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 4, 2009

Status Verified

August 1, 2009

First QC Date

September 12, 2005

Last Update Submit

August 3, 2009

Conditions

Colorectal Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

outpatients and inpatients of hospitals, subjects of parimary care clinics

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, 431-3192, Japan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

freces, biopsy tissue samples

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Shigeru Kanaoka, M.D.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

August 1, 1999

Study Completion

December 1, 2010

Last Updated

August 4, 2009

Record last verified: 2009-08

Locations

JP(1)