Implementation of Optical Diagnosis of Diminutive Colorectal Polyps: DISCARD3 Study (Incorporating AI-DETECT)

December 21, 2021 updated by: London North West Healthcare NHS Trust

Implementation of Optical Diagnosis of Diminutive Colorectal Polyps in Real Life Clinical Practice: DISCARD3 Study (Incorporating AI-DETECT)

This is a prospective feasibility study. The aim of this work is to assess the acceptability and feasibility of optical diagnosis-led care in bowel cancer screening patients undergoing colonoscopy. This study will determine whether bowel cancer screening colonoscopists are able to consistently record and diagnose diminutive adenomas suitable for a resect and discard strategy allowing assignment of surveillance intervals according to Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) criteria. A practical quality assurance program around optical diagnosis will be introduced. The use of a CAD polyp-detection system will also be evaluated (AI-DETECT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

614

Phase

  • Not Applicable

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

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

55 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 60-74

    • with +ve Faecal Occult Blood/Faecal Immunochemical test attending for screening colonoscopy within BCSP (Bowel Cancer Screening Programme)
    • with an established history of adenomas attending for surveillance colonoscopy within BCSP
  • Patients aged 55 - referred for screening colonoscopy following positive Bowel Scope Screening flexible sigmoidoscopy

Exclusion Criteria:

  • Patients with a risk profile (due to family history or other) whose follow-up will be outside standard BCSP
  • Patients with inflammatory bowel disease
  • Unable to consent
  • Pregnancy

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CAD polyp-detection system
In this arm, a CAD polyp detection system will be used during the colonoscopy.
Diagnostic test: CAD polyp-detection system
Software will be used during the procedure to aid the detection of polyps during the procedure.
No Intervention: Standard (no CAD polyp-detection system)
In this arm, a CAD polyp detection system will not be used during the colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Learning curve to achieve accurate optical diagnosis
Time Frame: Through study completion, approximately 18-24 months
The investigators will assess endoscopist learning curve by calculating percentage of accurate optical diagnoses of diminutive polyps (when compared with histopathology) for all endoscopists over the course of the study.
Through study completion, approximately 18-24 months
Proportion of cases where optical diagnosis derived surveillance intervals concur with histopathology derived surveillance intervals
Time Frame: 2 weeks for each participant
For each participant, the surveillance interval according to international guidelines (UK, US, European) will be determined based on optical diagnoses alone and then separately based on histopathology results alone. The proportion of cases where both optical diagnosis derived and histopathology derived surveillance intervals agree will be calculated.
2 weeks for each participant
Polyp detection rate (AI-DETECT)
Time Frame: 2 weeks for each participant
The investigators will assess the impact on polyp detection rate when using a CAD polyp-detection system.
2 weeks for each participant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of optical diagnosis
Time Frame: 2 weeks for each participant
The sensitivity of optical diagnosis will be assessed for polyps identified during the course of the study.
2 weeks for each participant
Specificity of optical diagnosis
Time Frame: 2 weeks for each participant
The specificity of optical diagnosis will be assessed for polyps identified during the course of the study.
2 weeks for each participant
Adenoma detection rate (AI-DETECT)
Time Frame: 2 weeks for each participant
The investigators will assess the impact on adenoma detection rate when using a CAD polyp-detection system.
2 weeks for each participant
Serrated polyp detection rate (AI-DETECT)
Time Frame: 2 weeks for each participant
The investigators will assess the impact on serrated polyp detection rate when using a CAD polyp-detection system.
2 weeks for each participant

Collaborators and Investigators

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

Sponsor

London North West Healthcare NHS Trust

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)

February 14, 2020

Primary Completion (Actual)

December 3, 2021

Study Completion (Actual)

December 3, 2021

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

December 22, 2021

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 245862

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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