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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: March 29, 2016
Last verified: March 2016

March 18, 2009
March 29, 2016
March 2010
March 2011   (final data collection date for primary outcome measure)
Proportion of enrolled patients who attend for their assigned screening test [ Time Frame: Immediate ] [ Designated as safety issue: No ]
Proportion of enrolled patients who attend for their assigned screening test [ Designated as safety issue: No ]
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. [ 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 ]
  • 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 ]
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
    FOBT
    Other Name: FOBT
  • Procedure: Virtual colonoscopy
    computed tomographic colonography
    Other Names:
    • CT colonography
    • computed tomographic colonography
  • Procedure: Optical colonoscopy
    optical (conventional / endoscopic) colonoscopy
    Other Name: Colonoscopy
  • Active Comparator: Fecal Occult Blood Test
    fecal occult blood test
    Intervention: Other: Fecal occult blood test
  • Active Comparator: Virtual Colonoscopy
    virtual colonoscopy
    Intervention: Procedure: Virtual colonoscopy
  • Active Comparator: Optical Colonoscopy
    optical (conventional / endoscopic) colonoscopy
    Intervention: Procedure: Optical colonoscopy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
198
September 2011
March 2011   (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   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00865527
CTC1.0
No
Not Provided
Not Provided
John You, McMaster University
Hamilton Health Sciences Corporation
McMaster University
Principal Investigator: John J You, MD MSc FRCPC McMaster University
McMaster University
March 2016

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