Clinical trial NCT04937647: Evaluation of Neoplasia with Artificial Intelligence in Gastrointestinal Endoscopy
Official title: Collection of Endoscopic Images and Videos for Validation of Artificial Intelligence Algorithms for Computer Aided Detection and Characterisation of Early Gastrointestinal Neoplasia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrointestinal Neoplasms
Keywords: gastrointestinal neoplasia
artificial intelligence
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2021-06-24
Enrollment: 1650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

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

Primary outcomes:
measure: neoplasia detection rate
timeFrame: during the procedure, up to 24 weeks, at 1 year, through study completion
Secondary outcomes:
measure: Accuracy of AI diagnosis
timeFrame: during the procedure, up to 24 weeks, at 1 year, through study completion
measure: Endoscopist neoplasia detection rate
timeFrame: during the procedure, up to 24 weeks, at 1 year, through study completion
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS University Trust
state: Hampshire
Study officials:
affiliation: Portsmouth Hospitals University NHS Trust
name: Pradeep Bhandari, Prof
role: PRINCIPAL_INVESTIGATOR
References: