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Computed Tomography (CT) Colonography Versus Optical Colonoscopy

This study is currently recruiting participants.
Verified April 2013 by University of British Columbia
Sponsor:
Collaborator:
Canadian Society of Intestinal Research
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01181739
First received: August 11, 2010
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

This study is designed to compare traditional Colonoscopy with CT Colonography, commonly known as "virtual colonoscopy". The study will compare the ability of both procedures as screening tests to identify polyps in the colon in patients at average risk for developing polyps. The patient preferences for each procedure will be assessed by means of a standardized questionnaire. As well the ability observers with differing levels of experience to read the CT scans and detect polyps will be compared. All patients will receive both CT scans and traditional colonoscopy on the same day.


Condition
Colonic Neoplasia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Effect of Experience and Training on the Accuracy of CT (Computed Tomography) Colonography in Comparison With Optical Colonoscopy in the Detection of Colonic Neoplasia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • CT colonography [ Time Frame: During procedure ] [ Designated as safety issue: No ]
    CT colonography (CTC), is a promising alternative to optical colonoscopy for use in widespread screening, as it requires no intravenous administration of sedatives or analgesia and little recovery time.


Biospecimen Retention:   Samples Without DNA

Colonic Mucosal Biopsy specimens obtained at the time of colonoscopy


Estimated Enrollment: 100
Study Start Date: October 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients 19 - 65 years of age at with a recognized indication for optical colonoscopy, including those high risk for colorectal cancer.

Criteria

Inclusion Criteria:

  • 19 - 65 years of age
  • Have a recognized indication for optical colonoscopy, including high risk for colorectal cancer
  • Over 45 years of age with a family history of colorectal cancer, those with positive screening tests (FOBT, DRE, flexible sigmoidoscopy and contrast enema)
  • Previous history of advanced adenomas and those with suggestive symptoms and signs (bleeding, abdominal pain, anemia)
  • Must be able to read and understand English and must be able to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181739

Contacts
Contact: Michelle Jones (604) 688-6332 ext 237

Locations
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Michelle Jones     (604) 688-6332 ext 237     michjon@telus.net    
Pacific Research Institute Recruiting
Vancouver, British Columbia, Canada
Contact: Michelle Jones     (604) 688-6332 ext 237     michjon@telus.net    
Sponsors and Collaborators
University of British Columbia
Canadian Society of Intestinal Research
Investigators
Principal Investigator: Robert Enns, Dr. University of British Columbia
Study Director: Jacquie Brown, Dr. University of British Columbia
Study Director: Jennifer Telford, Dr. University of British Columbia
Study Director: Gregory Rosenfeld, Dr. University of British Columbia
Study Director: Pari Tiwari, Dr. University of British Columbia
Study Director: Darin Krygier, Dr. University of British Columbia
Study Director: Brian Bressler, Dr. University of British Columbia
Study Director: Patrick Vos, Dr. University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01181739     History of Changes
Other Study ID Numbers: H08-00776
Study First Received: August 11, 2010
Last Updated: April 9, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Colonoscopy
Virtual Colonoscopy
Colonography
 Colorectal Cancer
Colonic Polyps
Screening

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013