Large Bowel PolypDN-PECNCT03545061
Dutch National Prospective EMR Cohort
An observational study of Large Bowel Polyp, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
A Prospective Study: Longterm Follow Up until S2 (2nd surveillance) at 18 months after EMR for Large Flat/Sessile Colonic Polyps. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Bowel Polyp
- How many people
- 2,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Aug 2018to Jul 2025
- How long will I take part?
- 18 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population is patients with 1 or more large flat or sessile polyps of 2 cm or larger, located in the colon, that are removed with EMR. These will often be patients diagnosed in the scope of the National Colon Cancer Screening programme.
Who may be able to join
- Flat or sessile polyp morphology (Paris classification 0-IIa/b/c, Is)
- Polyp size >20 mm
- Therapy: EMR
- Age > 18 years old
- Written informed consent
Who cannot join
- Participation in a competing study, such as the "CLIPPER trial" (registration number: NL62949.091.17).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525GA
Ayla Turan, MSc, 0611368110, ayla.turan@radboudumc.nl
About this study
Official title: Dutch National Prospective EMR Cohort. Longterm Follow Up After EMR for Large Flat/Sessile Colonic Polyps, a Prospective Study.
A Prospective Study: Longterm Follow Up until S2 (2nd surveillance) at 18 months after EMR for Large Flat/Sessile Colonic Polyps.
- Conditions
- Large Bowel Polyp
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Delayed bleeding, perforation and postpolypectomy syndrome
Measured: 30 days post EMR
Recurrence
Pathological and endoscopical re-appearance of adenoma
Measured: 6 months (S1) and 18 months (S2) after EMR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start6 Aug 2018
- Primary completionJul 2022 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Bowel PolypStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- 2,000 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- E. Van Geenen, dr, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545061
- Sponsor's protocol ID
- 2018-4449
- Acronym
- DN-PEC
- Status last verified
- Oct 2020
- First submitted
- 22 May 2018
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dutch National Prospective EMR Cohort. Longterm Follow Up After EMR for Large Flat/Sessile Colonic Polyps, a Prospective Study.
- ClinicalTrials.gov ID
- NCT03545061
- Acronym / sponsor ID
- DN-PEC / 2018-4449
- Conditions
- Large Bowel Polyp
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 4 Jun 2018 (actual)
- 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.
A Prospective Study: Longterm Follow Up until S2 (2nd surveillance) at 18 months after EMR for Large Flat/Sessile Colonic Polyps.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is patients with 1 or more large flat or sessile polyps of 2 cm or larger, located in the colon, that are removed with EMR. These will often be patients diagnosed in the scope of the National Colon Cancer Screening programme.
Key inclusion criteria (5 listed)
- Flat or sessile polyp morphology (Paris classification 0-IIa/b/c, Is)
- Polyp size >20 mm
- Therapy: EMR
- Age > 18 years old
- Written informed consent
Key exclusion criteria (1 listed)
- Participation in a competing study, such as the "CLIPPER trial" (registration number: NL62949.091.17).
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
Complications
Time frame: 30 days post EMR
Delayed bleeding, perforation and postpolypectomy syndrome
Recurrence
Time frame: 6 months (S1) and 18 months (S2) after EMR
Pathological and endoscopical re-appearance of adenoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
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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.
E. Van Geenen, dr principal investigator
Radboud University Medical Center
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 Large Bowel Polyp, run by Radboud University Medical Center at 1 site in Netherlands.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Oct 2020. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayla Turan, MSc (+31(0)611368110, ayla.turan@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 30 days post EMR). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2020.