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临床试验/NCT06504134
NCT06504134尚未招募不适用

Gastroesophageal Reflux Disease Diagnostic Trial

Changhai Hospital0 个研究点目标入组 1,000 人开始时间: 2024年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
主要终点
Diagnostic accuracy

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Diagnostic accuracy

时间窗: 60 minutes

sensitivity and specificity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luowei Wang, MD

Clinical Professor

Changhai Hospital

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