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
  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:


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 April 15, 2014