Dutch National Prospective EMR Cohort | NCT03545061

Studies
Dutch National Prospective EMR Cohort

NCT03545061

Sponsor

Radboud University Medical Center

Status

Unknown status

Last Update Posted

Oct 9, 2020Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Large Bowel Polyp

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 6, 2018Actual

Primary Completion Date

Jul 2022Estimated

Completion Date

Jul 2025Estimated

First Submitted Date

May 22, 2018

First Submission Date that Met QC Criteria

May 22, 2018

First Posted Date

Jun 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2020

Last Update Posted Date

Oct 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A Prospective Study: Longterm Follow Up until S2 (2nd surveillance) at 18 months after EMR for Large Flat/Sessile Colonic Polyps.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

18 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complications	Delayed bleeding, perforation and postpolypectomy syndrome	30 days post EMR
Recurrence	Pathological and endoscopical re-appearance of adenoma	6 months (S1) and 18 months (S2) after EMR

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Participation in a competing study, such as the "CLIPPER trial" (registration number: NL62949.091.17).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ayla Turan, MSc	Contact	+31(0)611368110		ayla.turan@radboudumc.nl

Overall Officials

Name	Affiliation	Role
E. Van Geenen, dr	Radboud University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboudumc	Recruiting	Nijmegen	Gelderland	6525GA	Netherlands