Clinical trial NCT00865527: Pilot Study of Colon Cancer Screening Tests
Official title: Randomized Comparison of Virtual Colonoscopy, Optical Colonoscopy, and Fecal Occult Blood Testing for Colorectal Cancer Screening: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Colon Cancer
Adenomatous Polyps
Keywords: Colorectal cancer
Colon cancer
Adenomatous polyps
Screening
Fecal occult blood test
Computed tomographic colonography
Colonoscopy
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2009-03-19
Enrollment: 198
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility 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

Primary outcomes:
measure: Proportion of enrolled patients who attend for their assigned screening test
timeFrame: Immediate
Secondary outcomes:
measure: Proportion of non-responders to mailed invitations, who respond to telephone or mail reminders.
timeFrame: Immediate
measure: Proportion of patients requiring polypectomy after virtual colonoscopy who receive same or next day optical colonoscopy for polypectomy
timeFrame: 6 months
measure: Proportion of subjects who cross over to another arm of the study
timeFrame: 6 months
measure: Proportion of patients found to have an advanced adenoma
timeFrame: 6 months
measure: Proportion of patients found to have invasive colorectal carcinoma
timeFrame: 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: McMaster University
name: John J You, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.