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Pilot Study of Colon Cancer Screening Tests

Primary Purpose

Colorectal Cancer, Colon Cancer, Adenomatous Polyps

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fecal occult blood test
Virtual colonoscopy
Optical colonoscopy
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Colorectal cancer, Colon cancer, Adenomatous polyps, Screening, Fecal occult blood test, Computed tomographic colonography, Colonoscopy

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hamilton Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Fecal Occult Blood Test

Virtual Colonoscopy

Optical Colonoscopy

Arm Description

fecal occult blood test

virtual colonoscopy

optical (conventional / endoscopic) colonoscopy

Outcomes

Primary Outcome Measures

Proportion of enrolled patients who attend for their assigned screening test

Secondary Outcome Measures

Proportion of non-responders to mailed invitations, who respond to telephone or mail reminders.
Proportion of patients requiring polypectomy after virtual colonoscopy who receive same or next day optical colonoscopy for polypectomy
Proportion of subjects who cross over to another arm of the study
Proportion of patients found to have an advanced adenoma
Proportion of patients found to have invasive colorectal carcinoma

Full Information

First Posted
March 18, 2009
Last Updated
March 29, 2016
Sponsor
Hamilton Health Sciences Corporation
Collaborators
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT00865527
Brief Title
Pilot Study of Colon Cancer Screening Tests
Official Title
Randomized Comparison of Virtual Colonoscopy, Optical Colonoscopy, and Fecal Occult Blood Testing for Colorectal Cancer Screening: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Why Stopped
Lack of ongoing funding
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamilton Health Sciences Corporation
Collaborators
McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colon Cancer, Adenomatous Polyps
Keywords
Colorectal cancer, Colon cancer, Adenomatous polyps, Screening, Fecal occult blood test, Computed tomographic colonography, Colonoscopy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fecal Occult Blood Test
Arm Type
Active Comparator
Arm Description
fecal occult blood test
Arm Title
Virtual Colonoscopy
Arm Type
Active Comparator
Arm Description
virtual colonoscopy
Arm Title
Optical Colonoscopy
Arm Type
Active Comparator
Arm Description
optical (conventional / endoscopic) colonoscopy
Intervention Type
Other
Intervention Name(s)
Fecal occult blood test
Other Intervention Name(s)
FOBT
Intervention Description
FOBT
Intervention Type
Procedure
Intervention Name(s)
Virtual colonoscopy
Other Intervention Name(s)
CT colonography, computed tomographic colonography
Intervention Description
computed tomographic colonography
Intervention Type
Procedure
Intervention Name(s)
Optical colonoscopy
Other Intervention Name(s)
Colonoscopy
Intervention Description
optical (conventional / endoscopic) colonoscopy
Primary Outcome Measure Information:
Title
Proportion of enrolled patients who attend for their assigned screening test
Time Frame
Immediate
Secondary Outcome Measure Information:
Title
Proportion of non-responders to mailed invitations, who respond to telephone or mail reminders.
Time Frame
Immediate
Title
Proportion of patients requiring polypectomy after virtual colonoscopy who receive same or next day optical colonoscopy for polypectomy
Time Frame
6 months
Title
Proportion of subjects who cross over to another arm of the study
Time Frame
6 months
Title
Proportion of patients found to have an advanced adenoma
Time Frame
6 months
Title
Proportion of patients found to have invasive colorectal carcinoma
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J You, MD MSc FRCPC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26156248
Citation
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.
Results Reference
derived
PubMed Identifier
23399518
Citation
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.
Results Reference
derived

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Pilot Study of Colon Cancer Screening Tests

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