Prediction of Dysplasia Within Sessile Serrated Polyps Using Endoscopic Imaging; a Prospective Observational Study (SERRESH)

June 28, 2023 updated by: Professor Michael Bourke, Western Sydney Local Health District
Study of endoscopic imaging in the detection of dysplasia within serrated colonic lesions >= 8mm in size

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Observational study Structured endoscopic imaging protocol devised Applied prospectively to sequential SSP >= 8mm detected in a tertiary endoscopic resection cohort Review of specimens by blinded specialist pathologists Review of incongruent cases by endoscopists and pathologists

Study Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients referred to a tertiary endoscopic resection practice with any SSP >= 8mm

Description

Inclusion Criteria:

  • Patients referred to a tertiary endoscopic resection practice with any sessile serrated polyp (SSP) >= 8mm

Exclusion Criteria:

  • Patients referred to a tertiary endoscopic resection practice without sessile serrated polyps (SSP)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study population
Patients referred to a tertiary endoscopic resection practice found to have an SSP >= 8mm. Endoscopic imaging applied to the sessile serrated polyp (SSP) to determine the presence or absence of dysplasia.
Diagnostic test: Endoscopic imaging
Analysis of the presence of dysplasia within sessile serrated polyps (SSP) using endoscopic imaging (high definition white light +- narrow band imaging)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysplasia
Time Frame: at the initial procedure when the sessile serrated polyp (SSP) is analysed by the endoscopist compared with when the SSP is analysed at histopathology less than one week later. no ongoing determination
Presence of dysplasia within sessile serrated polyps (SSP) using endoscopic imaging and congruence with histopathology
at the initial procedure when the sessile serrated polyp (SSP) is analysed by the endoscopist compared with when the SSP is analysed at histopathology less than one week later. no ongoing determination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sessile serrated polyp
Time Frame: at the initial procedure compared with histopathology within 1 week. no ongoing determination
Determination of a specific polyp as an sessile serrated polyp (SSP)
at the initial procedure compared with histopathology within 1 week. no ongoing determination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Sydney Local Health District

Investigators

  • Principal Investigator: Michael Bourke, MBBS, FRACP, WSLHD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

March 22, 2017

First Submitted That Met QC Criteria

March 28, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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