Evaluation of Neoplasia With Artificial Intelligence in Gastrointestinal Endoscopy

Study Overview
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Brief Summary
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This study aims to validate and evaluate AI algorithms for detection and characterization of early GI neoplasia.

Detailed Description
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This is an investigator initiated; multi-centre study and will be conducted in two phases. Validation & Optimization phase, where routinely collected and anonymized endoscopic images and videos from the departmental teaching and training library will be used to validate, and if needed fine-tune and improve, the accuracy of an AI algorithm. Testing phase, where the evaluation of AI algorithms performance will be conducted on a prospective basis. The ground truth (standard) will be expert assessment and histological diagnosis. This study has no direct impact on patient's clinical care, and collection of all endoscopic data will take place during standard endoscopy procedures done for purely clinical indications. No additional procedures, biopsies or interventions will be performed as a part of this study.

Official Title
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Collection of Endoscopic Images and Videos for Validation of Artificial Intelligence Algorithms for Computer Aided Detection and Characterisation of Early Gastrointestinal Neoplasia

Conditions
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Gastrointestinal Neoplasms

Intervention / Treatment
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* Other: collection of endoscopic images and videos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -The participant must meet ALL of the following criteria to be considered eligible for the study: Male or Female, aged 18 years or above. Requiring gastroscopy and/or colonoscopy to investigate gastrointestinal symptoms, or as part of screening or ongoing surveillance of GI neoplasia. Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria The participant may not enter the study if ANY of the following apply: Patients with endoscopically active severe oesophagitis Poor bowel preparation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: collection of endoscopic images and videos|collection of endoscopic images and videos|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neoplasia detection rate | neoplasia detection rate of the AI algorithms in different locations of the GI tract. | during the procedure, up to 24 weeks, at 1 year, through study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of AI diagnosis | Accuracy of real time optical diagnosis (characterization) of GI neoplasia by the AI algorithm. | during the procedure, up to 24 weeks, at 1 year, through study completion | 
| Endoscopist neoplasia detection rate | Detection rate of endoscopists at various levels of experience | during the procedure, up to 24 weeks, at 1 year, through study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrointestinal neoplasia, artificial intelligence