NCT03471793

Brief Summary

A prospective, multicentre, observational study of all patients referred for endoscopic resection of sessile colorectal polyps sized ≥20 mm conducted with intention to treat analysis

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
131mo left

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress46%
Feb 2017Feb 2037

Study Start

First participant enrolled

February 24, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2037

Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

9.9 years

First QC Date

March 13, 2018

Last Update Submit

March 25, 2025

Conditions

Colon AdenomaColon Polyp

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Follow up colonoscopies as per standard of care for 6 - 60 months noting and treating any recurrence.

    6-60months

Secondary Outcomes (2)

  • Technical success for Endoscopic resection

    6-60 months

  • Cancer prediction

    peri-procedurally

Study Arms (1)

Colonic polyp

Patients referred for EMR of a colonic polyp \>20mm

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred for colonic EMR of a known sessile colonic polyp or laterally spreading lesion \>20mm in size

You may qualify if:

  • Patients referred for endoscopic resection of a large sessile colonic polyp or laterally spreading tumour ≥20mm in size.
  • Able to give informed consent to involvement in the clinical study

You may not qualify if:

  • Unable to provide informed consent for involvement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Michael Bourke, MBBS

CONTACT

88905555michael@citywestgastro.com.au

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Interventional Endoscopy

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 21, 2018

Study Start

February 24, 2017

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2037

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

AU(1)