Pilot Study of Colon Cancer Screening Tests

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00865527
• Other study ID #: CTC1.0
• Status: Terminated
• Phase: N/A
• First received: March 18, 2009
• Last updated: January 31, 2012
• Start date: March 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2012
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 198
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Adenomatous Polyps
• Colon Cancer
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Fecal occult blood test

Procedure:
• Virtual colonoscopy

• Optical colonoscopy

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of enrolled patients who attend for their assigned screening test			No
Secondary	Proportion of non-responders to mailed invitations, who respond to telephone or mail reminders.			No
Secondary	Proportion of patients requiring polypectomy after virtual colonoscopy who receive same or next day optical colonoscopy for polypectomy			No
Secondary	Proportion of subjects who cross over to another arm of the study		6 months	No
Secondary	Proportion of patients found to have an advanced adenoma		6 months	No
Secondary	Proportion of patients found to have invasive colorectal carcinoma		6 months	No