Pilot Study of Colon Cancer Screening Tests

Study Overview
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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.

Official Title
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Randomized Comparison of Virtual Colonoscopy, Optical Colonoscopy, and Fecal Occult Blood Testing for Colorectal Cancer Screening: a Pilot Study

Conditions
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Colorectal Cancer, Colon Cancer, Adenomatous Polyps

Intervention / Treatment
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* Other: Fecal occult blood test
* Procedure: Virtual colonoscopy
* Procedure: Optical colonoscopy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fecal Occult Blood Test<br>fecal occult blood test | Other: Fecal occult blood test<br>* FOBT<br>* Other names: FOBT;|
| Active Comparator: Virtual Colonoscopy<br>virtual colonoscopy | Procedure: Virtual colonoscopy<br>* computed tomographic colonography<br>* Other names: computed tomographic colonography;|
| Active Comparator: Optical Colonoscopy<br>optical (conventional / endoscopic) colonoscopy | Procedure: Optical colonoscopy<br>* optical (conventional / endoscopic) colonoscopy<br>* Other names: Colonoscopy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of enrolled patients who attend for their assigned screening test |  | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Proportion of patients found to have invasive colorectal carcinoma |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Colon cancer, Adenomatous polyps, Screening, Fecal occult blood test, Computed tomographic colonography, Colonoscopy