Pilot Study of Colon Cancer Screening Tests

March 29, 2016 updated by: John You, Hamilton Health Sciences Corporation

Randomized Comparison of Virtual Colonoscopy, Optical Colonoscopy, and Fecal Occult Blood Testing for Colorectal Cancer Screening: a Pilot Study

Colon cancer is the second leading cause of cancer death in North America. These deaths are preventable with proper screening. Fecal occult blood testing, virtual colonoscopy, and standard (optical) colonoscopy are all options for colon cancer screening, but it is not known which is the best at preventing death from colon cancer. A large study comparing these three tests is desperately needed. In this pilot study, the investigators want to find out what percentage of patients will show up for their screening test once enrolled. This will provide crucial information for the successful execution of the larger study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Hamilton Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All individuals age 50 to 70 years

Exclusion Criteria:

  • Unable to give informed consent
  • History of colorectal cancer
  • History of adenomatous polyp
  • History of inflammatory bowel disease
  • Prior participation in FOBT screening
  • Prior refusal to participate in FOBT screening
  • Flexible sigmoidoscopy within the previous 3 years
  • Virtual colonoscopy within the previous 3 years
  • Optical colonoscopy within the previous 3 years
  • Severe of terminal illness that would preclude benefit from colon cancer screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fecal Occult Blood Test
fecal occult blood test
Other: Fecal occult blood test
FOBT
Other Names:
  • FOBT
Active Comparator: Virtual Colonoscopy
virtual colonoscopy
Procedure: Virtual colonoscopy
computed tomographic colonography
Other Names:
  • CT colonography
  • computed tomographic colonography
Active Comparator: Optical Colonoscopy
optical (conventional / endoscopic) colonoscopy
Procedure: Optical colonoscopy
optical (conventional / endoscopic) colonoscopy
Other Names:
  • Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of enrolled patients who attend for their assigned screening test
Time Frame: Immediate
Immediate

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of non-responders to mailed invitations, who respond to telephone or mail reminders.
Time Frame: Immediate
Immediate
Proportion of patients requiring polypectomy after virtual colonoscopy who receive same or next day optical colonoscopy for polypectomy
Time Frame: 6 months
6 months
Proportion of subjects who cross over to another arm of the study
Time Frame: 6 months
6 months
Proportion of patients found to have an advanced adenoma
Time Frame: 6 months
6 months
Proportion of patients found to have invasive colorectal carcinoma
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Collaborators

McMaster University

Investigators

  • Principal Investigator: John J You, MD MSc FRCPC, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

March 18, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 19, 2009

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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