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Gastroesophageal Reflux Disease Diagnostic Trial

NCT06504134 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-07-16

No results posted yet for this study

Summary

Gastroesophageal reflux disease (GERD) is a very common condition in clinical practice. In China, GERD affects nearly 150 million patients, whose quality of life are seriously impacted. Currently, the diagnosis of GERD primarily depends on the results of 24h reflux monitoring. However, such examination is under a quite low acceptability. As a result, a large number of patients were not diagnosed timely and accurately, and serious social problems are induced, such as drug abuse of proton pump inhibitor. Our team has previously developed a novel device for esophageal cell enrichment and established an internationally pioneering method of cytological screening for esophageal cancer based on cutting-edge deep learning technology. This project aims to develop multiple deep learning algorithms and establish an innovative method for diagnosis of GRED, using the novel esophageal cell enrichment technology. The research includes: 1) constructing deep learning algorithms for automatic esophageal inflammatory cells recognition and classification; 2) mining and extracting the key features of esophageal squamous cells and inflammatory cells under physician-AI interaction; 3) establishing a prediction model for GERD by integrating digital features of squamous cells and inflammatory cells and building a cloud-based automatic diagnosis system; 4) investigating the immuno-infiltration atlas of GERD and its diagnostic value based on the enriched inflammatory cells. The ultimate goal is to solve current clinical problems and realize rapid, convenient, and accurate diagnosis of GERD.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DIAGNOSTIC_TEST

the Novel Esophageal Cell Collection Device

Using the novel cell collection device and the deep learning method to collect and classify esophogeal cell to identify if the participants are GERD patients

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER

  • Ruijin Hospital

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Shanghai Tongji Hospital, Tongji University School of Medicine

    collaborator OTHER

  • The Second Affiliated Hospital of Baotou Medical College

    collaborator OTHER

  • Changhai Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-30
Primary Completion
2027-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06504134 on ClinicalTrials.gov