Colorectal Cancer, Colon Cancer, Adenomatous Polyps
Conditions
Keywords
Colorectal cancer, Colon cancer, Adenomatous polyps, Screening, Fecal occult blood test, Computed tomographic colonography, Colonoscopy
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.
Interventions
FOBT
PROCEDUREVirtual colonoscopy
computed tomographic colonography
PROCEDUREOptical colonoscopy
optical (conventional / endoscopic) colonoscopy
Sponsors
McMaster University
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of enrolled patients who attend for their assigned screening test | Immediate |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients found to have invasive colorectal carcinoma | 6 months |
| Proportion of non-responders to mailed invitations, who respond to telephone or mail reminders. | Immediate |
| Proportion of patients requiring polypectomy after virtual colonoscopy who receive same or next day optical colonoscopy for polypectomy | 6 months |
| Proportion of subjects who cross over to another arm of the study | 6 months |
| Proportion of patients found to have an advanced adenoma | 6 months |
Countries
Canada
Outcome results
None listed