AI for Onsite Cytology Evaluation in Endoscopic Ultrasound
Artificial Intelligence for Onsite Cytology Evaluation in Endoscopic Ultrasound
1 other identifier
observational
200
1 country
1
Brief Summary
The aim of this study is to determine if the widely available artificial intelligence platform ChatGPT can accurately identify the abnormalities present on cytology specimens obtained at EUS-FNB of solid mass lesions in the gastrointestinal tract, in comparison with interpretation by cytopathologists as the gold standard.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 12, 2025
CompletedFirst Submitted
Initial submission to the registry
November 13, 2025
CompletedFirst Posted
Study publicly available on registry
November 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
November 14, 2025
November 1, 2025
1.1 years
November 13, 2025
November 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy at rapid onsite evaluation
The ability of the AI system to correctly interpret cytology images, compared to cytopathologists.
1 day
Secondary Outcomes (1)
Diagnostic accuracy compared to final pathology
7 days
Study Arms (2)
Interpretation of cytology specimen by cytopathologist onsite
The interpretation of the cytology specimens will be made onsite by the cytopathologist
Interpretation of cytology specimen by artificial intelligence
The interpretation of the cytology specimens will be made onsite by the AI program
Interventions
EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract
Eligibility Criteria
Patients aged 18 years or greater, undergoing EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract.
You may qualify if:
- Age 18 years old or greater
- Patients undergoing EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract
You may not qualify if:
- Age less than 18 years
- Patients not undergoing sampling of solid mass lesions at EUS
- Patients with cystic lesions in the gastrointestinal tract
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orlando Health Digestive Health Institute
Orlando, Florida, 32806, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji Young Bang, MD MPH
Orlando Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2025
First Posted
November 14, 2025
Study Start
November 12, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
October 1, 2027
Last Updated
November 14, 2025
Record last verified: 2025-11