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Идёт набор NCT06039917

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

Без фазы С лечением Artificial Intelligence Surveillance

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: AI based automatic surveillance (AS) system (ENDOANGEL-AS), Manually remind the patients.
Кому может быть актуально
Состояния в реестре: Artificial Intelligence, Surveillance. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.
  • Другое Manually remind the patients
    Medical staff remind patients to review manually.

Первичные конечные точки

  • On-time Surveillance Rate [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
Вторичные конечные точки (11)
  • Surveillance Rate [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
  • Advance Surveillance Rate [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
  • Delayed Surveillance Rate [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
  • The accuracy of identifying patients with gastric premalignant lesions [Срок оценки: 1 day At the time of enrollment]
  • The accuracy of classifying risk levels [Срок оценки: 1 day At the time of enrollment]
  • The accuracy of assigning surveillance intervals [Срок оценки: 1 day At the time of enrollment]
  • lesion progression rate [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
  • lesion persistence rate [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
  • lesion regression rate [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
  • The incidence rate of early gastric cancer [Срок оценки: From enrollment to study completion, assessed up to 3 years.]
  • The incidence rate of gastric cancer [Срок оценки: From enrollment to study completion, assessed up to 3 years.]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Скрининг

Центры проведения

Китай · 4 центра
  • Jinjiang Municipal Hospital, Shanghai Sixth People's Hospital Fujian Campus — Quanzhou
  • The Eighth Hospital of Wuhan — Ухань
  • Renmin Hospital of Wuhan University — Ухань
  • Shanghai Pudong Hospital — Шанхай

Идентификаторы

NCT: NCT06039917 · EA-AS2023-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗