An Observational Study for Gastric Cancer in Carriers of High Risk Helicobacter Pylori
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: observational study.
- Кому может быть актуально
- Состояния в реестре: Gastric (Stomach) Cancer, Helicobacter Infection. Базовые параметры: от 40 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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Официальное название
Risk of Gastric Cancer in High-risk Carriers of Helicobacter Pylori: an Observational Cohort Study
Обзор
This study is intended to be a prospective observational cohort study. The incidence of gastric cancer and progression of gastric precancerous lesions will be compared between groups through prospective follow-up of a population with baseline negative gastric endoscopy, harboring high-risk Hp SNP subtypes and non-high-risk subtypes.
Подробное описание
Primary study objective: to assess the difference in the incidence of gastric cancer between carriers of high-risk SNP subtypes of H. pylori and the non-high-risk population during the follow-up period.
Secondary research objectives: 1. To observe and compare the cumulative incidence and progression of gastric precancerous lesions (e.g., atrophic gastritis, intestinal metaplasia, etc.) in each population group during the follow-up period.2. To explore the interaction of high-risk SNPs on the risk of gastric cancer in the context of different age, gender or other risk factors (e.g. diet, smoking, alcohol abuse, family history, etc.).
Вмешательства
- Другое observational study
By prospectively following a population of asymptomatic carriers carrying high-risk Hp SNP subtypes and non-high-risk subtypes, the incidence of gastric cancer and progression of gastric precancerous lesions were compared between the groups.
Первичные конечные точки
- Difference in incidence of gastric cancer between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) during a 3-year follow-up. [Срок оценки: From enrollment to the end of the study in 3 years]
Вторичные конечные точки (2)
- Difference in incidence of gastric cancer between the three groups (HP positive high-risk, HP positive non-high-risk, and HP negative) at 5-, and 10-year follow-up time points. [Срок оценки: From enrollment to the end of the study in 10 years]
- Differences in the incidence of gastric precancerous lesions among three groups (Hp-positive high-risk, Hp-positive non-high-risk, and Hp-negative) at 3-, 5-, and 10-year follow-up time points. [Срок оценки: From enrollment to the end of the study in 10 years]
Критерии участия
Критерии включения
- Age ≥ 40 years, gender is not limited.
- Able and willing to provide informed consent and willing to undergo baseline and follow-up examinations.
Критерии исключения
- A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
- Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical.
- Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
- Pregnant or breastfeeding women.
- Other conditions that the investigator deems inappropriate for participation in the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- People's Hospital of Tongling City — Tongling
Идентификаторы
NCT: NCT06896370 · 2025 observational study