Gastroesophageal Reflux Disease Diagnostic Trial (GERDT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Diagnostic test: the Novel Esophageal Cell Collection Device

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Luowei Wang, MD; Phone Number: 13901833088; Email: wangluoweimd@126.com
• Study Contact Backup: Name: Lei Xin, MD; Phone Number: 13817318134; Email: aip_xin@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Population who underwent testing with the novel esophageal cell collection device due to related symptoms from June 2024 to December 2027

Description

Inclusion Criteria:

1. ≥18 years and ≤85 years, male or female;
2. A visit was made for symptoms such as persistent reflux, heartburn, bloating, early satiety, and belching;
3. Patients volunteered to participate in the clinical trial, signed an informed consent form, and were able to cooperate with clinical follow-up.

Exclusion Criteria:

1. History of esophageal surgery;
2. Presence of dysphagia, esophagogastric fundal varices, or esophageal stenosis;
3. Presence of coagulation disorders or taking anticoagulant or antiplatelet drugs;
4. Those with a life expectancy of less than 5 years;
5. Persons with mental anomalies who are incapable of behavioral autonomy;
6. Other conditions that, in the judgment of the physician, preclude participation in the trial.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy	sensitivity and specificity	60 minutes

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: West China Hospital; Tongji Hospital; Ruijin Hospital; Wuhan Union Hospital, China; Shanghai Tongji Hospital, Tongji University School of Medicine; The Second Affiliated Hospital of Baotou Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 14, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 14, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic
• Other Study ID Numbers: GERDT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No