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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06039917
Other study ID # EA-AS2023-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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.
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