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Trial record 8 of 127 for:    colon cancer | ( Map: Canada )

Pilot Study of Colon Cancer Screening Tests

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00865527
Recruitment Status : Terminated (Lack of ongoing funding)
First Posted : March 19, 2009
Last Update Posted : March 31, 2016
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
John You, McMaster University

Tracking Information
First Submitted Date  ICMJE March 18, 2009
First Posted Date  ICMJE March 19, 2009
Last Update Posted Date March 31, 2016
Study Start Date  ICMJE March 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
Proportion of enrolled patients who attend for their assigned screening test [ Time Frame: Immediate ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2009)
Proportion of enrolled patients who attend for their assigned screening test
Change History Complete list of historical versions of study NCT00865527 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
  • Proportion of non-responders to mailed invitations, who respond to telephone or mail reminders. [ Time Frame: Immediate ]
  • Proportion of patients requiring polypectomy after virtual colonoscopy who receive same or next day optical colonoscopy for polypectomy [ Time Frame: 6 months ]
  • Proportion of subjects who cross over to another arm of the study [ Time Frame: 6 months ]
  • Proportion of patients found to have an advanced adenoma [ Time Frame: 6 months ]
  • Proportion of patients found to have invasive colorectal carcinoma [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2009)
  • Proportion of non-responders to mailed invitations, who respond to telephone or mail reminders.
  • Proportion of patients requiring polypectomy after virtual colonoscopy who receive same or next day optical colonoscopy for polypectomy
  • Proportion of subjects who cross over to another arm of the study [ Time Frame: 6 months ]
  • Proportion of patients found to have an advanced adenoma [ Time Frame: 6 months ]
  • Proportion of patients found to have invasive colorectal carcinoma [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Colon Cancer Screening Tests
Official Title  ICMJE Randomized Comparison of Virtual Colonoscopy, Optical Colonoscopy, and Fecal Occult Blood Testing for Colorectal Cancer Screening: a Pilot Study
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Colorectal Cancer
  • Colon Cancer
  • Adenomatous Polyps
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 31, 2012)
198
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2009)
600
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00865527
Other Study ID Numbers  ICMJE CTC1.0
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John You, McMaster University
Study Sponsor  ICMJE Hamilton Health Sciences Corporation
Collaborators  ICMJE McMaster University
Investigators  ICMJE
Principal Investigator: John J You, MD MSc FRCPC McMaster University
PRS Account McMaster University
Verification Date March 2016

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