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

Tracking Information

First Received Date ^ICMJE

March 18, 2009

Last Updated Date

January 31, 2012

Start Date ^ICMJE

March 2010

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00865527 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening

Condition ^ICMJE

Colorectal Cancer
Colon Cancer
Adenomatous Polyps

Intervention ^ICMJE

Other: Fecal occult blood test
Other Name: FOBT
Procedure: Virtual colonoscopy
Other Names:
- CT colonography
- computed tomographic colonography
Procedure: Optical colonoscopy
Other Name: Colonoscopy

Study Arm (s)

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

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

198

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (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

Gender

Both

Ages

50 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00865527

Other Study ID Numbers ^ICMJE

CTC1.0

Has Data Monitoring Committee

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

Information Provided By

McMaster University

Verification Date

January 2012

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

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