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Pilot Study of Colon Cancer Screening Tests

This study has been terminated.
(Lack of ongoing funding)
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
John You, McMaster University
ClinicalTrials.gov Identifier:
NCT00865527
First received: March 18, 2009
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by McMaster University:

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

Secondary Outcome Measures:
  • Proportion of non-responders to mailed invitations, who respond to telephone or mail reminders. [ Designated as safety issue: No ]
  • Proportion of patients requiring polypectomy after virtual colonoscopy who receive same or next day optical colonoscopy for polypectomy [ 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
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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 Procedure: Virtual colonoscopy
Other Names:
  • CT colonography
  • computed tomographic colonography
Active Comparator: Optical Colonoscopy Procedure: Optical colonoscopy
Other Name: Colonoscopy

  Eligibility

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

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

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

No publications provided by McMaster University

Additional 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: January 31, 2012
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on May 23, 2013