Идёт набор NCT05494021

China Lung Cancer Screening (CLUS) Study Version 3.0

Без фазы С лечением Lung Cancer

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: Whole-process management software, LDCT detection.
Кому может быть актуально: Состояния в реестре: Lung Cancer. Базовые параметры: 45 лет — 75 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

Lung Cancer Screening With Low-dose CT in China (CLUS Study) Version 3.0

Обзор

CLUS version 1.0, had proven that LDCT led to a 74.1% increase in detecting early-stage lung cancer compare to usual care (NCT02898441). CLUS version 2.0 evaluated the efficacy of new techniques (AI, AFI and MTB) in fostering the implementation of lung cancer screening (NCT03975504). The present multi-center study is performed to evaluate the effectiveness of different lung cancer screening strategy and validate our previous findings. 100,000 high-risk subjects (age 45-75) were recruited to take LDCT screening (Baseline + 2 biennial repeated LDCT screening). Follow-up for lung cancer incidence, lung cancer mortality and overall mortality was performed. Blood samples were stored in a Biobank. Management of positive screening test was carried out by a pre-specified protocol.

Вмешательства

Другое Whole-process management software
Enrolled participants will managed by a pre-designed software. The software would provide helpful assistance, such as lung cancer education, decision-making, assisting in making and attending LCS LDCT appointments, arranging follow-up when needed, tobacco cessation support for smokers, treatment assistance if diagnosed as lung cancer.
Устройство LDCT detection
LDCT were performed in both arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm

Первичные конечные точки

The mortality rate of lung cancer [Срок оценки: 5 years]
The attendance rate of high-risk individuals [Срок оценки: 5 years]
The adherence rate of high-risk individuals [Срок оценки: 5 years]

Вторичные конечные точки (3)

The mortality of all-cause [Срок оценки: 5 years]
The detection rate of lung nodules [Срок оценки: 5 years]
The incidence rate lung cancer [Срок оценки: 5 years]

Критерии участия

Критерии включения

Eligible participants were those aged 45-75 years, and with either of the following risk factors:

history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
malignant tumors history in immediate family members;
personal cancer history;
professional exposure to carcinogens;
long term exposure to second-hand smoke;
long term exposure to cooking oil fumes.