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NCT Number: NCT06039917

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Manually remind the patients

Other

Medical staff remind patients to review manually.

Primary outcomes

  1. On-time Surveillance Rate

    Time frame: From enrollment to study completion, assessed up to 3 years.

    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.

Secondary outcomes

  1. Surveillance Rate

    Time frame: From enrollment to study completion, assessed up to 3 years.

    The numerator is the number of patients with surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.

  2. Advance Surveillance Rate

    Time frame: From enrollment to study completion, assessed up to 3 years.

    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.

  3. Delayed Surveillance Rate

    Time frame: From enrollment to study completion, assessed up to 3 years.

    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.

  4. The accuracy of identifying patients with gastric premalignant lesions

    Time frame: 1 day At the time of enrollment

    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.

  5. The accuracy of classifying risk levels

    Time frame: 1 day At the time of enrollment

    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.

  6. The accuracy of assigning surveillance intervals

    Time frame: 1 day At the time of enrollment

    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.

  7. lesion progression rate

    Time frame: From enrollment to study completion, assessed up to 3 years.

    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.

  8. lesion persistence rate

    Time frame: From enrollment to study completion, assessed up to 3 years.

    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.

  9. lesion regression rate

    Time frame: From enrollment to study completion, assessed up to 3 years.

    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.

  10. The incidence rate of early gastric cancer

    Time frame: From enrollment to study completion, assessed up to 3 years.

    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.

  11. The incidence rate of gastric cancer

    Time frame: From enrollment to study completion, assessed up to 3 years.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Honggang Yu, PhD

CONTACT

[email protected]

13871281899

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Collaborators

  • Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus
  • Shanghai Pudong Hospital
  • The Eighth Hospital of Wuhan

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Sep 15, 2023
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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