Lung Cancer Screening With Low-dose CT Scan in Women : Implementation Study
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 Screening. Базовые параметры: 50 лет — 74 лет · Женщины.
- 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 purpose of this study is to determine whether reading of low-dose thoracic CT scans can be done by a single general radiologist who has been trained to lung cancer screening, and will evaluate the performance in comparison with double reading by experts. The study will enroll women between 50 and 74 years old, at risk for lung cancer due to their smoking history.
Подробное описание
Lung cancer is the leading cause of cancer death, worldwide. Several randomized studies have demonstrated that annual or biennial low-dose CT screening reduces lung cancer mortality. However, these studies involved expert chest radiologists, with double reading being performed in most studies. Furthermore, none of the published studies have evaluated the role of artificial intelligence to serve as second of concurrent reader.
Women with at least 20 pack-year smoking history who quitted smoking less than 15 years ago will be enrolled to have baseline, 1-year and 2-year low-dose CT of the chest.
The CT scans will be read on site by a general radiologist trained to lung cancer screening according to the European lung cancer screening certification program, first without then with the aid of an artificial algorithm trained to lung nodule detection (Veye Chest, Aidence). All CT scans will also be read by 2 chest experts, who will resolve their disagreement by a consensus reading if necessary. Patient management will rely on the double reading by expert. The criteria for positive screen result are as follows: solid nodule \> 500 mm3 (10 mm) or growing (30% volume increase), part-solid nodule with \> 8 mm solid component or new or growing, pure ground glass nodule developing a solid portion.
Вмешательства
- Процедура Low-dose computed tomography of the chest
Baseline low dose Ct acquisition, then at 1 year and 2 years to depict suspicious lung nodules
Первичные конечные точки
- Performance of trained radiologists for lung cancer screening [Срок оценки: 2 years]
Вторичные конечные точки (10)
- Effectiveness of screening [Срок оценки: 2 years]
- Analysis of the diagnostic performance of the reading without detection software, in order to assess its incremental value [Срок оценки: 2 years]
- Analysis of the performance of a reading by detection software alone [Срок оценки: 2 years]
- Analysis of the concordances of the different readings [Срок оценки: 2 years]
- Adherence to screening [Срок оценки: 2 years]
- Analysis of the impact of screening on smoking cessation [Срок оценки: 2 years]
- Psychological impact of screening [Срок оценки: 2 years]
- Number of co-morbidities (COPD, coronary artery disease) detected [Срок оценки: 2 years]
- Evaluation of costs induced by screening [Срок оценки: 2 years]
- Prevalence of osteoporosis by opportunistic screening [Срок оценки: 2 years]
Критерии участия
Критерии включения
- Women aged from 50 to 74 years
- who had smoked at least 20 pack years and quit less than 15 years ago
- Had given their consent and accepted the need for a 2-year follow-up
- Affiliated to the social security system
Критерии исключения
- Presence of clinical symptoms suggesting malignancy (weight loss, hemoptysis) or ongoing infection (cough with fever)
- Evolving cancer
- History of lung cancer
- A 2-year follow-up not possible
- Chest CT scan performed within 2 years prior to inclusion
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
Франция · 1 центр
- Hôtel-Dieu — Paris
Публикации
- Revel MP, Abdoul H, Chassagnon G, Canniff E, Durand-Zaleski I, Wislez M. Lung CAncer SCreening in French women using low-dose CT and Artificial intelligence for DEtection: the CASCADE study protocol. BMJ Open. 2022 Dec 8;12(12):e067263. doi: 10.1136/bmjopen-2022-067263. PMID 36600392
Идентификаторы
NCT: NCT05195385 · APHP210362 · 2021-A02265-36