Pilot Study of Colon Cancer Screening Tests

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

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer; Adenomatous Polyps; Colon Cancer
• Intervention / Treatment: Other: Fecal occult blood test; Procedure: Virtual colonoscopy; Procedure: Optical colonoscopy

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Hamilton Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fecal Occult Blood Test; fecal occult blood test	Other: Fecal occult blood test; FOBT; Other Names: FOBT
Active Comparator: Virtual Colonoscopy; virtual colonoscopy	Procedure: Virtual colonoscopy; computed tomographic colonography; Other Names: CT colonography; computed tomographic colonography
Active Comparator: Optical Colonoscopy; optical (conventional / endoscopic) colonoscopy	Procedure: Optical colonoscopy; optical (conventional / endoscopic) colonoscopy; Other Names: Colonoscopy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hamilton Health Sciences Corporation
• Collaborators: McMaster University
• Investigators: Principal Investigator: John J You, MD MSc FRCPC, McMaster University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: March 18, 2009
• First Submitted That Met QC Criteria: March 18, 2009
• First Posted (Estimate): March 19, 2009

Study Record Updates

• Last Update Posted (Estimate): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Colorectal cancer; Screening; Colonoscopy; Colon cancer; Adenomatous polyps; Fecal occult blood test; Computed tomographic colonography
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Adenoma; Colorectal Neoplasms; Colonic Neoplasms; Adenomatous Polyps
• Other Study ID Numbers: CTC1.0