Pilot Study of Colon Cancer Screening Tests

NCT ID: NCT00865527

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-09-30

Brief Summary

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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

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Conditions

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Colorectal Cancer Colon Cancer Adenomatous Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Fecal Occult Blood Test

fecal occult blood test

Group Type ACTIVE_COMPARATOR

Fecal occult blood test

Intervention Type OTHER

FOBT

Virtual Colonoscopy

virtual colonoscopy

Group Type ACTIVE_COMPARATOR

Virtual colonoscopy

Intervention Type PROCEDURE

computed tomographic colonography

Optical Colonoscopy

optical (conventional / endoscopic) colonoscopy

Group Type ACTIVE_COMPARATOR

Optical colonoscopy

Intervention Type PROCEDURE

optical (conventional / endoscopic) colonoscopy

Interventions

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Fecal occult blood test

FOBT

Intervention Type OTHER

Virtual colonoscopy

computed tomographic colonography

Intervention Type PROCEDURE

Optical colonoscopy

optical (conventional / endoscopic) colonoscopy

Intervention Type PROCEDURE

Other Intervention Names

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FOBT CT colonography computed tomographic colonography Colonoscopy

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McMaster University

OTHER

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role lead

Responsible Party

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John You

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John J You, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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You JJ, Liu Y, Kirby J, Vora P, Moayyedi P. Virtual colonoscopy, optical colonoscopy, or fecal occult blood testing for colorectal cancer screening: results of a pilot randomized controlled trial. Trials. 2015 Jul 9;16:296. doi: 10.1186/s13063-015-0826-7.

Reference Type DERIVED
PMID: 26156248 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23399518 (View on PubMed)

Other Identifiers

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CTC1.0

Identifier Type: -

Identifier Source: org_study_id

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