The Role of Artificial Intelligence in Endoscopic Diagnosis of Esophagogastric Junctional Adenocarcinoma:A Single Center, Case-control, Diagnostic Study

NCT ID: NCT05819099

Last Updated: 2023-11-18

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-31

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a single center, case-control, diagnostic study.The aim of this study is to use deep learning methods to retrospectively analyze the imaging data of gastrointestinal endoscopy in Qilu Hospital, and construct an artificial intelligence model based on endoscopic images for detecting and determining the depth of invasion of esophagogastric junctional adenocarcinoma.This study will also compare the established AI model with the diagnostic results of endoscopists to evaluate the clinical auxiliary value of the model for endoscopists.The research includes stages such as data collection and preprocessing, artificial intelligence model development, model testing and evaluation. The gastroscopy image dataset constructed by this research institute mainly includes three modes of endoscopic imaging: white light endoscopy, optical enhancement endoscopy (OE), and narrowband imaging endoscopy (NBI).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stomach Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Training Set

An Intelligent Endoscopic Diagnosis System Developed and Verified Based on Deep Learning

Intervention Type DIAGNOSTIC_TEST

This study will compare the established AI model with the diagnostic results of endoscopists to evaluate the clinical auxiliary value of the model for endoscopists.

Test Set

An Intelligent Endoscopic Diagnosis System Developed and Verified Based on Deep Learning

Intervention Type DIAGNOSTIC_TEST

This study will compare the established AI model with the diagnostic results of endoscopists to evaluate the clinical auxiliary value of the model for endoscopists.

Verification Set

An Intelligent Endoscopic Diagnosis System Developed and Verified Based on Deep Learning

Intervention Type DIAGNOSTIC_TEST

This study will compare the established AI model with the diagnostic results of endoscopists to evaluate the clinical auxiliary value of the model for endoscopists.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

An Intelligent Endoscopic Diagnosis System Developed and Verified Based on Deep Learning

This study will compare the established AI model with the diagnostic results of endoscopists to evaluate the clinical auxiliary value of the model for endoscopists.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* This study included endoscopic images of patients aged 18 and above who underwent endoscopic examination or treatment
* All patients in the case group need to be pathologically confirmed as esophageal gastric junction adenocarcinoma, and a pathologist has conducted a standardized pathological evaluation of the tumor classification of the lesion, including the overall appearance, size, differentiation type, depth of infiltration, presence or absence of lymphatic/vascular invasion, surgical margin status, etc.
* The endoscopic images of the control group patients need to be confirmed by biopsy pathology or at least two experienced endoscopists (with operating experience\>5000 cases) to jointly confirm that they have clear benign manifestations

Exclusion Criteria

* The patient has a previous history of endoscopic treatment or surgery for the esophageal gastric junction.
* Necessary clinical information cannot be provided during the research process (patient age, gender, lesion characteristics, endoscopic manifestations, endoscopic images, etc.)
* Low quality endoscopic images, such as those severely affected by bleeding, aperture, blurring, defocusing, artifacts, or excessive mucus after biopsy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Miaomiao Ma, Bachelor

Role: CONTACT

+8617657686098

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023SDU-QILU-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.