Pilot Study of Colon Cancer Screening Tests

NCT00865527 | Terminated

• 1 other identifier: CTC1.0
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colon Cancer; Adenomatous Polyps

Keywords

Colorectal cancer; Colon cancer; Adenomatous polyps; Screening; Fecal occult blood test; Computed tomographic colonography; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Proportion of enrolled patients who attend for their assigned screening test

  Immediate

Secondary Outcomes (5)

• 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

Study Arms (3)

Fecal Occult Blood Test

ACTIVE COMPARATOR

fecal occult blood test

Other: Fecal occult blood test

Virtual Colonoscopy

ACTIVE COMPARATOR

virtual colonoscopy

Procedure: Virtual colonoscopy

Optical Colonoscopy

ACTIVE COMPARATOR

optical (conventional / endoscopic) colonoscopy

Procedure: Optical colonoscopy

Interventions

Fecal occult blood test OTHER

FOBT

Also known as: FOBT

Fecal Occult Blood Test

Virtual colonoscopy PROCEDURE

computed tomographic colonography

Also known as: CT colonography, computed tomographic colonography

Virtual Colonoscopy

Optical colonoscopy PROCEDURE

optical (conventional / endoscopic) colonoscopy

Also known as: Colonoscopy

Optical Colonoscopy

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All individuals age 50 to 70 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (2)

• 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.

  PMID: 26156248 DERIVED

• 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.

  PMID: 23399518 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Adenomatous Polyps

Interventions

Occult Blood; Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• John J You, MD MSc FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: March 19, 2009
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

CA (1)