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Computed Tomography (CT) Colonography Versus Optical Colonoscopy

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ClinicalTrials.gov Identifier: NCT01181739
Recruitment Status : Unknown
Verified April 2013 by University of British Columbia.
Recruitment status was:  Recruiting
First Posted : August 13, 2010
Last Update Posted : April 11, 2013
Sponsor:
Collaborator:
Canadian Society of Intestinal Research
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
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 or disease
Colonic Neoplasia

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 100 participants
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
Study Start Date : October 2008
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. CT colonography [ Time Frame: During procedure ]
    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


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01181739     History of Changes
Other Study ID Numbers: H08-00776
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013

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

Additional relevant MeSH terms:
Neoplasms