Automatic surveillance system for patients with gastric premalignant lesions
Effect of the Automatic Surveillance System on Surveillance Rate of Patients with Gastric Premalignant Lesions
This study is testing whether an automatic monitoring system can help people with gastric premalignant lesions keep up with their check-ups better than manual reminders or no help at all.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1460 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Renmin Hospital of Wuhan University Academic / other |
| Locations | 4 sites (Quanzhou, Fujian and 3 other locations) |
| Trial ID | NCT06039917 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an automatic surveillance system designed to improve the monitoring of patients with gastric premalignant lesions. Participants will be divided into three groups: one receiving intelligent surveillance via an AI system, another receiving manual reminders, and a control group with no intervention. The goal is to compare the surveillance rates among these groups to determine the impact of the automatic system. This approach aims to enhance adherence to surveillance guidelines, which is crucial for early detection and management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who are undergoing upper endoscopy and have gastric premalignant lesions.
Not a fit: Patients with high-grade intraepithelial neoplasia, esophageal or gastric cancer, or those deemed unsuitable for clinical trials will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the surveillance rates for patients with gastric premalignant lesions, leading to better patient outcomes.
How similar studies have performed: Previous studies have shown promise in using automatic surveillance systems for patient monitoring, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female aged 18 years or older who undergo upper endoscopy. Exclusion Criteria: * 1)No contact information or invalid contact information. * 2\) The surveillance interval cannot be determined according to the surveillance guidelines, including no upper gastrointestinal pathology, therapeutic endoscopy or with history of previous gastrectomy, esophagectomy, or ESD, no dysplasia degrees, no biopsy sites, non-epithelial lesions, duodenal lesions, ulcer and so on. * 3\) Needless for surveillance or others. * 4\) High-grade intraepithelial neoplasia or cancer of the esophagus or stomach. * 5\) Low-grade intraepithelial neoplasia of the esophagus and Barrett's esophagus. * 6\) High-risk diseases or other special conditions for which the patient is deemed unsuitable for clinical trials by the investigator.
Where this trial is running
Quanzhou, Fujian and 3 other locations
- Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus — Quanzhou, Fujian, China (Not_yet_recruiting)
- The Eighth Hospital of Wuhan — Wuhan, Hubei, China (Not_yet_recruiting)
- Renmin Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
- Shanghai Pudong Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Honggang Yu, PhD — Renmin Hospital of Wuhan University
- Study coordinator: Honggang Yu, PhD
- Email: yuhonggang1968@163.com
- Phone: 13871281899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.