AI for Onsite Cytology Evaluation in Endoscopic Ultrasound

NCT ID: NCT07228689

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-12

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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The diagnostic accuracy of EUS-guided fine needle biopsy of lesions in the gastrointestinal tract is dependent on the availability of a cytopathologist to render a rapid on-site evaluation (ROSE), with studies showing that the presence of an on-site cytopathologist improves the diagnostic yield, decreases the number of inadequate or unsatisfactory samples, and limits the number of passes required to establish a diagnosis. However, the availability of ROSE is variable across centers and regions, with the availability of onsite cytopathology services limited to a handful of tertiary referral centers in the United States.

ChatGPT is a universally available, generative artificial intelligence program developed by OpenAI. The aim of this study is to determine if this AI platform 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.

Conditions

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Gastrointestinal Neoplasm Mass Lesion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Interpretation of cytology specimen by cytopathologist onsite

The interpretation of the cytology specimens will be made onsite by the cytopathologist

EUS-guided fine needle biopsy

Intervention Type DIAGNOSTIC_TEST

EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract

Interpretation of cytology specimen by artificial intelligence

The interpretation of the cytology specimens will be made onsite by the AI program

EUS-guided fine needle biopsy

Intervention Type DIAGNOSTIC_TEST

EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract

Interventions

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EUS-guided fine needle biopsy

EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 18 years old or greater
* Patients undergoing EUS-guided fine needle biopsy of solid mass lesions in the gastrointestinal tract

Exclusion Criteria

* Age less than 18 years
* Patients not undergoing sampling of solid mass lesions at EUS
* Patients with cystic lesions in the gastrointestinal tract
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orlando Health, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ji Young Bang, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Orlando Health

Locations

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Orlando Health Digestive Health Institute

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ji Young Bang, MD MPH

Role: CONTACT

321.842.2273

Barbara J Broome

Role: CONTACT

321.842.6416

Facility Contacts

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Barbara J Broome

Role: primary

321-842-6416

Other Identifiers

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2343877

Identifier Type: -

Identifier Source: org_study_id

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