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

Tracking Information

First Received Date ^ICMJE

April 27, 2009

Last Updated Date

July 16, 2010

Start Date ^ICMJE

August 2008

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00888771 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Discard:Characterisation of Colonic Polyps in Vivo

Official Title ^ICMJE

Characterisation of Small Colonic Polyps in Vivo

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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

Condition ^ICMJE

Colorectal Polyps

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Publications *

Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. Epub 2009 Nov 10.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

130

Completion Date

June 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Patients with known colitis or polyposis syndromes
Unable or unwilling to give informed consent

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00888771

Other Study ID Numbers ^ICMJE

05/Q0405/121/1

Has Data Monitoring Committee

Responsible Party

Dr Brian Saunders, Wolfson Unit for Endoscopy, St Mark's Hospital, Watford Road, Harrow HA1 3UJ

Study Sponsor ^ICMJE

Imperial College London

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Brian P Saunders, MD

Wolfson Unit for Endoscopy, St Mark's Hospital

Information Provided By

Imperial College London

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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