NCT06039917

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,460

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Sep 2023Dec 2029

First Submitted

Initial submission to the registry

September 9, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

September 10, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

November 4, 2024

Status Verified

August 1, 2024

Enrollment Period

5.3 years

First QC Date

September 9, 2023

Last Update Submit

November 1, 2024

Conditions

Artificial IntelligenceSurveillance

Keywords

surveillance rateautomatic surveillance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Surveillance Rate

    From enrollment to study completion, assessed up to 3 years.

  • Advance Surveillance Rate

    From enrollment to study completion, assessed up to 3 years.

  • Delayed Surveillance Rate

    From enrollment to study completion, assessed up to 3 years.

  • The accuracy of identifying patients with gastric premalignant lesions

    1 day At the time of enrollment

  • The accuracy of classifying risk levels

    1 day At the time of enrollment

  • +6 more secondary outcomes

Study Arms (3)

With automatic surveillance system

EXPERIMENTAL

Patients were reminded of the surveillance time by an automatic surveillance system after the endoscopic and pathological results were available and before the surveillance time.

Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS)

With manual reminder

EXPERIMENTAL

Patients were reminded of the surveillance time manually after the endoscopic and pathological results were available and before the surveillance time.

Other: Manually remind the patients

Normal group

NO INTERVENTION

The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder.

Interventions

AI based automatic surveillance (AS) system (ENDOANGEL-AS)OTHER

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.

With automatic surveillance system
Manually remind the patientsOTHER

Medical staff remind patients to review manually.

With manual reminder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 18 years or older who undergo upper endoscopy.

You may not qualify if:

  • )No contact information or invalid contact information.
  • \) 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.
  • \) Needless for surveillance or others.
  • \) 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 for which the patient is deemed unsuitable for clinical trials by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus

Quanzhou, Fujian, China

NOT YET RECRUITING

The Eighth Hospital of Wuhan

Wuhan, Hubei, 430014, China

NOT YET RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, 201399, China

RECRUITING

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Honggang Yu, PhD

    Renmin Hospital of Wuhan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Honggang Yu, PhD

CONTACT

13871281899yuhonggang1968@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2023

First Posted

September 15, 2023

Study Start

September 10, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

November 4, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)