Pilot Study of Colon Cancer Screening Tests

This study has been terminated.
(Lack of ongoing funding)
McMaster University
Information provided by (Responsible Party):
John You, McMaster University
ClinicalTrials.gov Identifier:
First received: March 18, 2009
Last updated: March 29, 2016
Last verified: March 2016
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.

Condition Intervention
Colorectal Cancer
Colon Cancer
Adenomatous Polyps
Other: Fecal occult blood test
Procedure: Virtual colonoscopy
Procedure: Optical colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Randomized Comparison of Virtual Colonoscopy, Optical Colonoscopy, and Fecal Occult Blood Testing for Colorectal Cancer Screening: a Pilot Study

Resource links provided by NLM:

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Proportion of enrolled patients who attend for their assigned screening test [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of non-responders to mailed invitations, who respond to telephone or mail reminders. [ Time Frame: Immediate ] [ Designated as safety issue: No ]
  • Proportion of patients requiring polypectomy after virtual colonoscopy who receive same or next day optical colonoscopy for polypectomy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of subjects who cross over to another arm of the study [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of patients found to have an advanced adenoma [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Proportion of patients found to have invasive colorectal carcinoma [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 198
Study Start Date: March 2010
Study Completion Date: September 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fecal Occult Blood Test
fecal occult blood test
Other: Fecal occult blood test
Other Name: 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 Name: Colonoscopy


Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865527

Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Hamilton Health Sciences Corporation
McMaster University
Principal Investigator: John J You, MD MSc FRCPC McMaster University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John You, Assistant Professor, McMaster University
ClinicalTrials.gov Identifier: NCT00865527     History of Changes
Other Study ID Numbers: CTC1.0 
Study First Received: March 18, 2009
Last Updated: March 29, 2016
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Colorectal cancer
Colon cancer
Adenomatous polyps
Fecal occult blood test
Computed tomographic colonography

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

ClinicalTrials.gov processed this record on May 26, 2016