NCT00888771

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

April 27, 2009

Last Update Submit

August 4, 2022

Conditions

Keywords

Colorectal cancerpolypscolonoscopyadvanced imaging

Outcome Measures

Primary Outcomes (1)

  • Accuracy of polyp characterisation

    12 months

Secondary Outcomes (1)

  • Change in surveillance interval after formal histopathology

    12 months

Study Arms (4)

1

2

3

4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson Unit for Endoscopy, St Mark's Hospital

Harrow, Moddlesex, HA1 3UJ, United Kingdom

Location

Related Publications (1)

  • 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. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10.

MeSH Terms

Conditions

Colorectal NeoplasmsPolyps

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Brian P Saunders, MD

    Wolfson Unit for Endoscopy, St Mark's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 28, 2009

Study Start

August 1, 2008

Primary Completion

February 1, 2009

Study Completion

June 1, 2009

Last Updated

August 5, 2022

Record last verified: 2022-08

Locations