Actively Recruiting
Effect of the Automatic Surveillance System on Surveillance Rate of Patients with Gastric Premalignant Lesions
Led by Renmin Hospital of Wuhan University · Updated on 2024-11-04
1460
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
R
Renmin Hospital of Wuhan University
Lead Sponsor
S
Shanghai Pudong Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how an automatic surveillance system affects the monitoring rates of patients with gastric premalignant lesions. This prospective study compares three groups: one using an intelligent automatic surveillance system, another with manual reminders from medical staff, and a control group under natural surveillance conditions. The study aims to improve adherence to surveillance guidelines, which is often inconsistent and time-consuming for doctors. The study involves an AI-based automatic surveillance (AS) system called ENDOANGEL-AS that identifies patients, assigns surveillance intervals based on risk, and proactively follows up at specific times. Patients in the manual reminder group receive surveillance prompts from medical staff, while the control group receives no special reminders. The study compares these three approaches over time. Participants will be monitored from enrollment for up to three years. Researchers will assess on-time surveillance rates, overall surveillance rates, and rates of advanced or delayed surveillance. Additional outcomes include the accuracy of patient identification and risk classification, lesion progression, persistence, regression, and incidence rates of early gastric and gastric cancer. The study includes regular evaluations based on endoscopic and pathological results.
CONDITIONS
Brief Title
Effect of the Automatic Surveillance System on Surveillance Rate of Patients with Gastric Premalignant Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older who undergo upper endoscopy.
You will not qualify if you...
- No contact information or invalid contact information.
- Surveillance interval cannot be determined due to lack of upper gastrointestinal pathology, therapeutic endoscopy, previous gastrectomy, esophagectomy, or endoscopic submucosal dissection.
- No dysplasia degrees, no biopsy sites, non-epithelial lesions, duodenal lesions, ulcers, or others making surveillance unnecessary.
- High-grade intraepithelial neoplasia or cancer of the esophagus or stomach.
- Low-grade intraepithelial neoplasia of the esophagus and Barrett's esophagus.
- High-risk diseases or other special conditions making the patient unsuitable for clinical trials as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants are monitored to assess the effectiveness of different surveillance methods for gastric premalignant lesions, including an automatic surveillance system, manual reminders, or natural observation.
Surveillance visits as determined by assigned group
Trial Site Locations
Total: 4 locations
1
Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
Quanzhou, Fujian, China
Not Yet Recruiting
2
The Eighth Hospital of Wuhan
Wuhan, Hubei, China, 430014
Not Yet Recruiting
3
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060
Actively Recruiting
4
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, China, 201399
Actively Recruiting
Research Team
H
Honggang Yu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
3
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