Clinical trial NCT06039917: Effect of the Automatic Surveillance System on Surveillance Rate of Patients with Gastric Premalignant Lesions
Official title: Effect of the Automatic Surveillance System on Surveillance Rate of Patients with Gastric Premalignant Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Artificial Intelligence
Surveillance
Keywords: surveillance rate
automatic surveillance
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
Collaborators: name: Shanghai Pudong Hospital
name: The Eighth Hospital of Wuhan
name: Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
First posted: 2023-09-15
Enrollment: 1460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of patients with gastric premalignant lesions. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups will be compared.

Detailed description: The adherence of doctors to published surveillance guidelines for patients with gastric premalignant lesions varies greatly, and surveillance of patients is critical but time-consuming. In previous studies we developed an automatic surveillance (AS) system to accurately identify patients with gastric premalignant lesions, assign surveillance intervals for different risks of patients and proactively follow up with patients in time. In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of patients with gastric premalignant lesions. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups will be compared.

Eligibility 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.

Primary outcomes:
measure: On-time Surveillance Rate
timeFrame: From enrollment to study completion, assessed up to 3 years.
Secondary outcomes:
measure: Surveillance Rate
timeFrame: From enrollment to study completion, assessed up to 3 years.
measure: Advance Surveillance Rate
timeFrame: From enrollment to study completion, assessed up to 3 years.
measure: Delayed Surveillance Rate
timeFrame: From enrollment to study completion, assessed up to 3 years.
measure: The accuracy of identifying patients with gastric premalignant lesions
timeFrame: 1 day At the time of enrollment
measure: The accuracy of classifying risk levels
timeFrame: 1 day At the time of enrollment
measure: The accuracy of assigning surveillance intervals
timeFrame: 1 day At the time of enrollment
measure: lesion progression rate
timeFrame: From enrollment to study completion, assessed up to 3 years.
measure: lesion persistence rate
timeFrame: From enrollment to study completion, assessed up to 3 years.
measure: lesion regression rate
timeFrame: From enrollment to study completion, assessed up to 3 years.
measure: The incidence rate of early gastric cancer
timeFrame: From enrollment to study completion, assessed up to 3 years.
measure: The incidence rate of gastric cancer
timeFrame: From enrollment to study completion, assessed up to 3 years.
Other outcomes:
Locations:
city: Quanzhou
country: China
facility: Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
state: Fujian
city: Wuhan
country: China
facility: The Eighth Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Shanghai
country: China
facility: Shanghai Pudong Hospital
state: Shanghai
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Honggang Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References: