Implementing Low-dose ct Lung Cancer Screening in France.
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: Low-dose computed tomography of the chest.
- Кому может быть актуально
- Состояния в реестре: Lung Cancer. Базовые параметры: 50 лет — 74 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
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The main objective is to estimate the detection rate of lung cancer in the population screened by low-dose chest CT scans.
Подробное описание
Low-dose CT screening (LDCT) allows for the detection of lung cancer at an early stage, enabling curative treatment. Large randomized controlled trials have demonstrated that LDCT reduces mortality in smokers.
The objective of the current research is not to confirm a reduction in mortality, but to show that screening can be safely implemented at a population level. Different modes of recruitment and invitation will be tested to ensure that LDCT can be implemented equitably. The role of artificial intelligence as an alternative to double human reading will also be assessed.
Screening strategy includes baseline, followed by 1-year LDCT, and a third LDCT 2 years later. Current smokers will be offered smoking cessation support.
The management of screen-detected lung nodules will follow the 2025 guidelines from the European Society of Thoracic imaging.
Вмешательства
- Процедура Low-dose computed tomography of the chest
Baseline low-dose CT acquisition, then at 1 year and 3 years to depict suspicious lung nodules
Первичные конечные точки
- Lung cancer detection rate in the population screened using low-dose chest CT [Срок оценки: 42 months]
Вторичные конечные точки (12)
- Evaluation of screening performance [Срок оценки: 42 months]
- Exploration and comparison of several methods for identifying and inviting the target population [Срок оценки: 18 months]
- Measurement of participation rate [Срок оценки: 18 months]
- Measurement of response rates to follow-up invitations [Срок оценки: 42 months]
- Measurement of adherence to screening rounds [Срок оценки: 18 months , 30 months & 54 months]
- Measurement of the complication rate of invasive investigations in positive cases (true positives and false positives) [Срок оценки: 42 months]
- Measurement of the adherence rate to the offered smoking cessation support [Срок оценки: 48 months]
- Measurement of the adherence rate to smoking cessation support [Срок оценки: 48 months]
- Identification of reasons for refusal of smoking cessation support. [Срок оценки: 48 months]
- Measurement of smoking cessation rate [Срок оценки: 48 months]
- Identification of the predictors of smoking cessation rates. [Срок оценки: 48 months]
- Evaluation of the feasibility and relevance of a double reading of CT scans, and role of artificial intelligence [Срок оценки: 12 months]
Критерии участия
Критерии включения
- Adults aged 50-74 years
- Active or former smoker having quit less than 15 years ago
- Smoking history of at least 20 pack-years, or 15 cigarettes/day for 25 years or 10 cigarettes/day for 30 years
- Affiliation with a social security scheme
- Written informed consent prior to study participation
Temporary exclusion Criteria
- Chest CT scan performed within the previous 12 months
- Signs of respiratory infection (fever, productive cough)
Критерии исключения
- Severe co-morbidities contraindicating exploration and/or management (including stereotactic surgery or radiotherapy) of lung cancers
- Poor general status (PS2 and above)
- Rest dyspnea (mMRC4)
- Cancer under active surveillance by thoracic computed tomography (CT pr PET-CT)
- Personal history of lung cancer
- Symptoms raising suspicion of lung cancer (hemoptysis, unexplained weight loss, recent onset or modification of respiratory symptoms,…)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Скрининг
Центры проведения
Франция · 2 центра
- HCL - Hôpital Lyon Sud — Lyon
- Hôpital Cochin — Paris
Идентификаторы
NCT: NCT07513818 · APHP250243 · ID-RCB Number