Early DiAgnosis Real-Time Healthcare System for CANcer Trial

NCT05064124 | Recruiting

• 1 other identifier: 143608
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess whether the AI characterisation system of the CADDIE device improves the endoscopists accuracy in the optical diagnosis of diminutive colorectal polyps in the bowel during colonoscopy. Participants will either have a colonoscopy with the assistance of the CADDIE device characterisation AI system ("intervention group") or have a colonoscopy in line with routine clinical practice i.e., without the CADDIE device characterisation AI system ("control group"). The randomisation method of this trial will allocate enrolled participants to the "intervention" group and to the "control" group by a technique similar to flipping a coin.

Conditions

Polyps; Adenoma Colon; Colorectal Polyp; Colon Polyp; Polyps of Colon

Keywords

Artificial intelligence; Endoscopy; ADR

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to evaluate whether the CADDIE system improves endoscopists accuracy in the optical diagnosis of diminutive colorectal polyps (≤5mm).

  The primary endpoint will be the proportion of diminutive colorectal polyps optically diagnosed correctly by endoscopists (correct optical diagnoses divided by total number of diminutive polyps), expressed as a percentage, in the CADDIE arm compared to the control arm, with the polyp histopathology being referenced as the ground truth.

  1 year

Secondary Outcomes (8)

• To determine whether using the CADDIE system improves endoscopists accuracy in the optical diagnosis of diminutive polyps in the rectosigmoid area.

  1 year

• To determine whether using the CADDIE system improves the negative predicator value (NPV) of endoscopists for optically diagnosing diminutive adenomatous polyps in the rectosigmoid area.

  1 year

• To assess the concordance of colonoscopy surveillance intervals in the CADDIE arm determined using endoscopists optical diagnosis against histopathology derived surveillance intervals (ground truth).

  1 year

• To assess the concordance of colonoscopy surveillance intervals in the control arm determined using endoscopists optical diagnosis against histopathology derived surveillance intervals (ground truth).

  1 year

• To compare the accuracy of the colonoscopy surveillance intervals when the endoscopists uses the CADDIE system (CADDIE arm) compared to without the CADDIE system (control arm).

  1 year

Study Arms (2)

CADDIE

Participants will have a colonoscopy with the assistance of the CADDIE device characterisation AI system

Device: CADDIE - Computer Aided Detection and Diagnosis for Intelligent Endoscopy

Control group

Participants will have a colonoscopy in line with routine clinical practice i.e., without the CADDIE device characterisation AI system

Interventions

CADDIE - Computer Aided Detection and Diagnosis for Intelligent Endoscopy DEVICE

1. CADDIE assisted polyp detection 2. CADDIE assisted polyp characterisation

CADDIE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants scheduled to undergo a screening, surveillance or symptomatic colonoscopy at UCLH

You may qualify if:

• Participants scheduled to undergo a screening, surveillance or symptomatic colonoscopy with an endoscopist participating in the study phase of the trial.
• Male and female participants aged 18 years or older at the time of informed consent.
• Participants able to comprehend, sign and date the written informed consent document to participate in the study.

You may not qualify if:

• Emergency and/or inpatient colonoscopies
• Participants with inflammatory bowel disease (IBD)
• Participants with current Colorectal Cancer (CRC)
• Participants with a contraindication for biopsy or polypectomy. These include:
• Participants who have not withheld medications pre-disposing to bleeding at time of colonoscopy as per local site /national guidelines.
• Participants with a history of haemostasis disorders (haemostasis disorders will include but will not be limited to: participants with haemophilia or other congenitally acquired clotting factor deficiencies, participants with cirrhosis with coagulopathy, participants known to have thrombocytopenia (\<80,000 platelet/ul) and individuals with Von Willebrand's disease or other known platelet malfunction disorders)
• Participant is enrolled in another research study with an investigational medicinal product (IMP) or non-IMP that pre-disposes them to bleeding

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Polyps; Colonic Polyps

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Polyps

Study Officials

• Manish Chand, MBBS FRCS PhD

  UCL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Cheung, MSc

CONTACT

02076795217; sharon.cheung@ucl.ac.uk

Rawen Kader, MBBS MRCP

CONTACT

02076795217; rawen.kader.17@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 1, 2021
• Study Start: July 18, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available from 1 year after the trial findings are published. This is available for up to 5 years after study completion.
• Access Criteria: We will make provision for and consider data sharing requests from bona fide researchers who must abide by the following principles: data will be collected with an high level of quality assurance, data will be held securely with appropriate documentation, data will not be put into the public domain or otherwise shared without explicit ethical review or legal obligation, and they will aim to use any data generated to the maximum public good. These datasets are governed by data usage policies specified by the data controller (UCL). If a conflict exists that severely restricts the analyses that can be undertaken, we would endeavour to support outside researchers by hosting them as visiting workers in our team so that they can access the data. We are committed to complying with the Wellcome Trust Data Sharing Policy. Applications are subject to review by Laurence Lovat and Rawen Kader and should be emailed to l.lovat@ucl.ac.uk

Locations

GB (1)