Colorectal PolypsDISCARDNCT00888771
Discard:Characterisation of Colonic Polyps in Vivo
An observational study of Colorectal Polyps, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Prospective study of accuracy of colonic polyp characterisation in vivo using high resolution white light endoscopy, narrow band imaging and chromoendoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyps
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2008to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients with known colitis or polyposis syndromes
- Unable or unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wolfson Unit for Endoscopy, St Mark's Hospital
Harrow, Moddlesex, HA1 3UJ
About this study
Official title: Characterisation of Small Colonic Polyps in Vivo
Prospective study of accuracy of colonic polyp characterisation in vivo using high resolution white light endoscopy, narrow band imaging and chromoendoscopy.
- Conditions
- Colorectal Polyps
- Keywords
- Colorectal cancer, polyps, colonoscopy, advanced imaging
- Medical subject headings
- Colorectal Neoplasms, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described | |
| 3 | Not described | |
| 4 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of polyp characterisation
Measured: 12 months
Secondary outcomes (1)
Change in surveillance interval after formal histopathology
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startAug 2008
- Primary completionFeb 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian P Saunders, MD, Principal investigator, Wolfson Unit for Endoscopy, St Mark's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888771
- Sponsor's protocol ID
- 05/Q0405/121/1
- Acronym
- DISCARD
- Status last verified
- Aug 2022
- First submitted
- 27 Apr 2009
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10.
PubMed 19910250
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Small Colonic Polyps in Vivo
- ClinicalTrials.gov ID
- NCT00888771
- Acronym / sponsor ID
- DISCARD / 05/Q0405/121/1
- Conditions
- Colorectal Polyps
- Keywords
- Colorectal cancer, polyps, colonoscopy, advanced imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective study of accuracy of colonic polyp characterisation in vivo using high resolution white light endoscopy, narrow band imaging and chromoendoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
| 3 | – | – |
| 4 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- Patients over 18 years of age, assessed as fit for routine colonoscopy
- Patients attending for screening or surveillance colonoscopy meeting the following criteria:
Key exclusion criteria (2 listed)
- Patients with known colitis or polyposis syndromes
- Unable or unwilling to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of polyp characterisation
Time frame: 12 months
1 secondary outcome
Change in surveillance interval after formal histopathology
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Derived from this study: PubMed 19910250Ignjatovic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian P Saunders, MD principal investigator
Wolfson Unit for Endoscopy, St Mark's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Polyps, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of polyp characterisation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00888771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.