Evaluation of Neoplasia With Artificial Intelligence in Gastrointestinal Endoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: collection of endoscopic images and videos.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Collection of Endoscopic Images and Videos for Validation of Artificial Intelligence Algorithms for Computer Aided Detection and Characterisation of Early Gastrointestinal Neoplasia
Overview
This study aims to validate and evaluate AI algorithms for detection and characterization of early GI neoplasia.
Detailed description
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.
Interventions
- Other collection of endoscopic images and videos
collection of endoscopic images and videos
Primary outcome measures
- neoplasia detection rate [Time frame: during the procedure, up to 24 weeks, at 1 year, through study completion]
Secondary outcome measures (2)
- Accuracy of AI diagnosis [Time frame: during the procedure, up to 24 weeks, at 1 year, through study completion]
- Endoscopist neoplasia detection rate [Time frame: during the procedure, up to 24 weeks, at 1 year, through study completion]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United Kingdom · 1 center
- Portsmouth Hospitals NHS University Trust — Portsmouth
Identifiers
NCT: NCT04937647 · PHT/2020/58