Early DiAgnosis Real-Time Healthcare System for CANcer Trial
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Emergency and/or inpatient colonoscopies
Participants with inflammatory bowel disease (IBD)
Participants with current Colorectal Cancer (CRC)
Participants who have not withheld medications pre-disposing to bleeding at time of colonoscopy as per local site /national guidelines.
Trial population
Participants scheduled to undergo a screening, surveillance or symptomatic colonoscopy at UCLH
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CADDIE - Computer Aided Detection and Diagnosis for Intelligent Endoscopy
Device1. CADDIE assisted polyp detection 2. CADDIE assisted polyp characterisation
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: CADDIE1 intervention
Group B: Control group0 interventions
Trial outcomes
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.
Time frame
1 yearSecondary outcomes
1
To determine whether using the CADDIE system improves endoscopists accuracy in the optical diagnosis of diminutive polyps in the rectosigmoid area.
The endpoint will be the proportion of diminutive rectosigmoid colorectal polyps optically diagnosed correctly by endoscopists (correct optical diagnoses divided by total number of diminutive rectosigmoid polyps), expressed as a percentage, in the CADDIE arm compared to the control arm, with the polyp histopathology being referenced as the ground truth.
Time frame
1 year2
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.
The endpoint will be the NPV in optically diagnosing rectosigmoid diminutive adenomas in the CADDIE arm compared to the control arm, with the polyp histopathology being referenced as the ground truth.
Time frame
1 year3
To assess the concordance of colonoscopy surveillance intervals in the CADDIE arm determined using endoscopists optical diagnosis against histopathology derived surveillance intervals (ground truth).
The concordance of colonoscopy surveillance intervals in the CADDIE arm when using endoscopists CADDIE assisted OD in comparison to histopathology derived intervals (ground truth) - per patient analysis.
Time frame
1 year4
To assess the concordance of colonoscopy surveillance intervals in the control arm determined using endoscopists optical diagnosis against histopathology derived surveillance intervals (ground truth).
The concordance of colonoscopy surveillance intervals in the control arm when using endoscopists OD without the CADDIE system in comparison to histopathology derived intervals (ground truth) - per patient analysis.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov