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This study aims to validate and evaluate AI algorithms for detection and characterization of early GI neoplasia.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collection of endoscopic images and videos | Other | collection of endoscopic images and videos |
| 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 |
| 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 |
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Inclusion Criteria:
-The participant must meet ALL of the following criteria to be considered eligible for the study:
Exclusion Criteria
The participant may not enter the study if ANY of the following apply:
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In phase (1), all previously collected, anonymized and stored endoscopic images and videos of early GI neoplasia in the departmental endoscopy teaching and training library. In phase (2), all eligible patients coming for upper and/or lower GI endoscopy for clinical reasons in participating centres will be approached for enrolment into this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Marshall | Contact | 02392286000 | 5210 | Laura.Marshall2@porthosp.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Pradeep Bhandari, Prof | Portsmouth Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portsmouth Hospitals NHS University Trust | Recruiting | Portsmouth | Hampshire | PO63LY | United Kingdom |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
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Detection rate of endoscopists at various levels of experience
| during the procedure, up to 24 weeks, at 1 year, through study completion |
| D005767 |
| Gastrointestinal Diseases |
| D013676 |
| Technology, Industry, and Agriculture |
| D013690 | Television |