Discard:Characterisation of Colonic Polyps in Vivo - Full Text View

Discard:Characterisation of Colonic Polyps in Vivo (DISCARD)

This study is currently recruiting participants.

Verified by Imperial College London, April 2009

First Received: April 27, 2009 No Changes Posted

Sponsor:	Imperial College London
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00888771

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:	Cohort, Prospective
Official Title:	Characterisation of Small Colonic Polyps in Vivo

Resource links provided by NLM:

MedlinePlus related topics: Colonic Polyps Endoscopy

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Groups/Cohorts
1
2
3
4

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888771

Contacts

Contact: Ana Ignjatovic, BA BMBCh

02082354225

drana@doctors.org.uk

Locations

United Kingdom, Moddlesex
Wolfson Unit for Endoscopy, St Mark's Hospital	Recruiting
Harrow, Moddlesex, United Kingdom, HA1 3UJ
Contact: Ana Ignjatovic drana@doctors.org.uk

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 National Clinical Trials Identifier (NCT ID):

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.

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

Keywords provided by Imperial College London:

Colorectal cancer
polyps
colonoscopy
advanced imaging

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Intestinal Polyps
Colonic Polyps
Polyps

ClinicalTrials.gov processed this record on February 08, 2010