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

March 18, 2009
January 31, 2012
March 2010
December 2012   (final data collection date for primary outcome measure)
Proportion of enrolled patients who attend for their assigned screening test [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865527 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pilot Study of Colon Cancer Screening Tests
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
  • Colorectal Cancer
  • Colon Cancer
  • Adenomatous Polyps
  • Other: Fecal occult blood test
    Other Name: FOBT
  • Procedure: Virtual colonoscopy
    Other Names:
    • CT colonography
    • computed tomographic colonography
  • Procedure: Optical colonoscopy
    Other Name: Colonoscopy
  • Active Comparator: Fecal Occult Blood Test
    fecal occult blood test
    Intervention: Other: Fecal occult blood test
  • Active Comparator: Virtual Colonoscopy
    Intervention: Procedure: Virtual colonoscopy
  • Active Comparator: Optical Colonoscopy
    Intervention: Procedure: Optical colonoscopy
Wong AD, Kirby J, Guyatt GH, Moayyedi P, Vora P, You JJ. Randomized controlled trial comparing telephone and mail follow-up for recruitment of participants into a clinical trial of colorectal cancer screening. Trials. 2013 Feb 11;14:40. doi: 10.1186/1745-6215-14-40.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
198
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
50 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00865527
CTC1.0
No
John You, McMaster University
Hamilton Health Sciences Corporation
McMaster University
Principal Investigator: John J You, MD MSc FRCPC McMaster University
McMaster University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP