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Discard:Characterisation of Colonic Polyps in Vivo (DISCARD)

This study has been completed.
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00888771
First received: April 27, 2009
Last updated: July 16, 2010
Last verified: July 2010
History of Changes
  Purpose

Prospective study of accuracy of colonic polyp characterisation in vivo using high resolution white light endoscopy, narrow band imaging and chromoendoscopy.


Condition
Colorectal Polyps

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterisation of Small Colonic Polyps in Vivo

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Accuracy of polyp characterisation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in surveillance interval after formal histopathology [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study group therefore would comprise those presenting for 3 yearly follow up or sooner i.e. those with a resected colorectal cancer or those with ≥ three adenomas or one advanced ≥10mm adenoma or those with a positive faecal occult blood test

Criteria

Inclusion Criteria:

  1. Patients over 18 years of age, assessed as fit for routine colonoscopy

  2. Patients attending for screening or surveillance colonoscopy meeting the following criteria:

    • Polyp surveillance with at least 3 adenomas or 1 adenoma>10mm at previous colonoscopy
    • Surveillance post colorectal cancer resection
    • Screening with positive faecal occult blood test

Exclusion Criteria:

  1. Patients with known colitis or polyposis syndromes
  2. Unable or unwilling to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888771

Locations
United Kingdom
Wolfson Unit for Endoscopy, St Mark's Hospital
Harrow, Moddlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Brian P Saunders, MD Wolfson Unit for Endoscopy, St Mark's Hospital
  More Information

No publications provided by Imperial College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Brian Saunders, Wolfson Unit for Endoscopy, St Mark's Hospital, Watford Road, Harrow HA1 3UJ
ClinicalTrials.gov Identifier: NCT00888771     History of Changes
Other Study ID Numbers: 05/Q0405/121/1
Study First Received: April 27, 2009
Last Updated: July 16, 2010
Health Authority: United Kingdom: National Health Service

Keywords provided by Imperial College London:
Colorectal cancer
polyps
colonoscopy
advanced imaging

Additional relevant MeSH terms:
Colonic Polyps
Polyps
Intestinal Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013