NCT02617992

Brief Summary

The development of a standardised imaging protocol to detect post endoscopic mucosal resection (EMR) recurrence or residual adenoma through the comparison of biopsies of the post EMR scar with endoscopic findings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

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

September 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

November 8, 2015

Last Update Submit

March 22, 2021

Conditions

Polyps

Outcome Measures

Primary Outcomes (1)

  • Presence of post-EMR recurrence

    Presence of post-EMR recurrence

    one year

Secondary Outcomes (8)

  • Histological characteristics of post-EMR scar biopsies

    one year

  • Scar size

    one year

  • Presence of post EMR scar with clip artifact

    one year

  • Number of sites of recurrence

    one year

  • Location of recurrence

    one year

  • +3 more secondary outcomes

Study Arms (1)

EMR Surveillance

Patients who are referred for Endoscopic Mucosal Resection of Upper Gastrointestinal Lesions undertaking a surveillance visit will be included in this cohort.

Eligibility Criteria

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

Patients who have had endoscopic mucosal resection of colonic polyps that are undergoing surveillance colonoscopy.

You may qualify if:

  • Patients undergoing surveillance colonoscopy of a previously resected large sessile colonic polyp or laterally spreading tumour ≥20mm in size.
  • Age \> 18 years
  • 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 Hospital

Westmead, New South Wales, 2145, Australia

Location

MeSH Terms

Conditions

Polyps

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Bourke, MBBS

    Western Sydney Local Health District

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 8, 2015

First Posted

December 1, 2015

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations

AU(1)