Effect of the Automatic Surveillance System on Surveillance Rate of Patients With Gastric Premalignant Lesions

Artificial Intelligence Clinical Trial

Official title:

Effect of the Automatic Surveillance System on Surveillance Rate of Patients With Gastric Premalignant Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06039917
• Other study ID #: EA-AS2023-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 10, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: June 2023
• Source: Renmin Hospital of Wuhan University
• Contact: Honggang Yu, PhD
• Phone: 13871281899
• Email: yuhonggang1969[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1460
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Artificial Intelligence
• Precancerous Conditions
• Surveillance

Intervention

Other:
• AI based automatic surveillance (AS) system (ENDOANGEL-AS)
An automatic surveillance (AS) system accurately identify patients with gastric premalignant lesions, assign surveillance intervals for different risks of patients and proactively follow up with patients at certain times.
• Manually remind the patients
Medical staff remind patients to review manually.

Locations

Country	Name	City	State
China	Shanghai Pudong Hospital	Shanghai	Shanghai
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University	Shanghai Pudong Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	On-time Surveillance Rate	The numerator is the number of patients with on-time surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.	From enrollment to study completion, assessed up to 3 years.
Secondary	Surveillance Rate	The numerator is the number of patients with surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.	From enrollment to study completion, assessed up to 3 years.
Secondary	Advance Surveillance Rate	The numerator is the number of patients with surveillance in advance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.	From enrollment to study completion, assessed up to 3 years.
Secondary	Delayed Surveillance Rate	The numerator is the number of patients with delayed surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.	From enrollment to study completion, assessed up to 3 years.
Secondary	The accuracy of identifying patients with gastric premalignant lesions	The numerator is the number of patients correctly identified by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions.	1 day At the time of enrollment
Secondary	The accuracy of classifying risk levels	The numerator is the number of patients correctly classified by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions.	1 day At the time of enrollment
Secondary	The accuracy of assigning surveillance intervals	The numerator is the number of patients correctly assigned by automated surveillance system, and the denominator is the number of all enrolled patients with gastric premalignant lesions.	1 day At the time of enrollment
Secondary	lesion progression rate	The numerator is the number of patients with lesion progression, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.	From enrollment to study completion, assessed up to 3 years.
Secondary	lesion persistence rate	The numerator is the number of patients with lesion persistence, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.	From enrollment to study completion, assessed up to 3 years.
Secondary	lesion regression rate	The numerator is the number of patients with lesion regression, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.	From enrollment to study completion, assessed up to 3 years.
Secondary	The incidence rate of early gastric cancer	The numerator is the number of patients with early gastric cancer in surveillance endoscopy, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.	From enrollment to study completion, assessed up to 3 years.
Secondary	The incidence rate of gastric cancer	The numerator is the number of patients with gastric cancer in surveillance endoscopy, and the denominator is the number of all patients with gastric premalignant lesions undergoing surveillance.	From enrollment to study completion, assessed up to 3 years.