Pilot Study of Colon Cancer Screening Tests

Not Applicable

Terminated

• Conditions: Colorectal Cancer; Colon Cancer; Adenomatous Polyps
• Interventions: Procedure: Virtual colonoscopy; Procedure: Optical colonoscopy; Other: Fecal occult blood test

• Registration Number: NCT00865527
• Lead Sponsor: Hamilton Health Sciences Corporation

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 available

Study Timeline

• Study First Submitted: 2009-03-18
• Study First Submitted QC: 2009-03-18
• Study First Posted: 2009-03-19
• Study Start: 2010-03
• Primary Completion: 2011-03
• Study Completion: 2011-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Colonoscopy	Virtual colonoscopy	virtual colonoscopy
Optical Colonoscopy	Optical colonoscopy	optical (conventional / endoscopic) colonoscopy
Fecal Occult Blood Test	Fecal occult blood test	fecal occult blood test

Primary Outcome Measures

Name	Time	Method
Proportion of enrolled patients who attend for their assigned screening test	Immediate

Secondary Outcome Measures

Name	Time	Method
Proportion of patients found to have an advanced adenoma	6 months
Proportion of non-responders to mailed invitations, who respond to telephone or mail reminders.	Immediate
Proportion of patients found to have invasive colorectal carcinoma	6 months
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

Trial Locations

Locations (1)

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada