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Идёт набор NCT05387005

Screening Strategy for Gastric Cancer Prevention

Без фазы С лечением H. Pylori Infection

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: UBT, HPSA, UBT and HPSA, Serology (two stage).
Кому может быть актуально
Состояния в реестре: H. Pylori Infection. Базовые параметры: от 20 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
Тайвань
Следующий шаг
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Официальное название

Identification of the Optimal Screening Strategy for Gastric Cancer Prevention

Обзор

There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies. A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of diagnostic tests in a population-based H. pylori screening and gastric cancer prevention program. Initially, we planned to recruit 10,000 adults aged ≥20 years who had not previously undergone H. pylori screening or treatment. Eligible participants were to be randomly allocated in a 1:1:1:1 ratio to one of four groups, each receiving a different combination of diagnostic tests. However, a preliminary analysis led to a recalculation of the required sample size. Following the approval of an Institutional Review Board (IRB) amendment, enrollment was discontinued for Group B (HpSA method) and Group D (Two-stage screening method). The final number of participants enrolled in Group B and Group D was 852 and 851, respectively. Groups A (UBT method) and Group C (standard method) will continue to enroll participants through an additional 1:1 randomization until each group reaches a total of 1,350 participants.

Подробное описание

Background: There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies.

Objective: A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of C13 UBT and HpSA in a population-based H. pylori screening and gastric cancer prevention program.

Methods：Open labeled, randomized controlled trial Initially, the investigators will recruit adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients were randomly 1:1:1:1 allocated to (A) The carbon-13 urea breath test (C13 UBT), (B) H. pylori stool antigen test (Vstrip® HpSA), (C) Standard method (Both C13 UBT and HpSA), (D) Two-stage screening method (serology screening only, and then C13 UBT for confirmation if serology test is positive). However, a preliminary analysis led to a recalculation of the required sample size. Following the approval of an Institutional Review Board (IRB) amendment, enrollment was discontinued for Group B and Group D. The final number of participants enrolled in Group B and Group D was 852 and 851, respectively. Groups A and Group C will continue to enroll participants through an additional 1:1 randomization until each group reaches a total of 1,350 participants.

Outcome analysis:

1. Detection rate of H. pylori infection 2. To compare the compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups. 3. To assess the diagnostic accuracy of these tests. 4. To verify the compliance(/adherence) and feasibility of this two-stage screening method 5. Long-term Outcomes: To assess the risk reduction of gastric cancer

Вмешательства

  • Диагностический тест UBT
    H. pylori diagnostic test: C13 urea breath test
  • Диагностический тест HPSA
    H. pylori diagnostic test: H. pylori stool antigen test
  • Диагностический тест UBT and HPSA
    H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test
  • Диагностический тест Serology (two stage)
    H. pylori diagnostic test: If H. pylori serology is positive, confirmation UBT will be done.

Первичные конечные точки

  • Detection rates of H. pylori infection [Срок оценки: 2-8 weeks]
Вторичные конечные точки (1)
  • The compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups [Срок оценки: 2 weeks to 1 year]

Критерии участия

Критерии включения

  • Adults aged 20 years or older
  • Never screened and treated for H. pylori infection

Критерии исключения

  • Ever undergone gastrectomy
  • Patients with gastric cancer
  • Have been screened or tested for H. pylori infection
  • Ever received H. pylori eradication therapy
  • Have taken proton pump inhibitor within two weeks
  • Have taken antibiotics within two weeks

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Тайвань · 1 центр
  • National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT05387005 · 202203064RINC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗