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Pilot Study of Colon Cancer Screening Tests

This study has been terminated.
(Lack of ongoing funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00865527
First Posted: March 19, 2009
Last Update Posted: March 31, 2016
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.
Collaborator:
McMaster University
Information provided by (Responsible Party):
John You, McMaster University
  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: None (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 John You, McMaster University:

Primary Outcome Measures:
  • Proportion of enrolled patients who attend for their assigned screening test [ Time Frame: Immediate ]

Secondary Outcome Measures:
  • 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 ]

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
FOBT
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 18, 2009
First Posted: March 19, 2009
Last Update Posted: March 31, 2016
Last Verified: March 2016

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

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