Understanding Lung Cancer Related Risk Factors and Their Impact
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Lung Cancer Screening. Базовые параметры: 40 лет — 80 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
- Бельгия, Латвия, Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
LUCIA aims to develop prediction models for the early diagnosis of lung cancer based on the identification of risk factors and deeper cellular knowledge, by recording real-world data; with risk assessment tools, non-invasive devices and omics analysis. These models will enable new clinical pathways and diagnostic workflow to be implemented to ensure early diagnosis and confirmation, including classification of lung cancer subtype.
Подробное описание
Lung cancer is the leading cause of cancer death worldwide, causing more deaths than breast and prostate cancer combined.
The current five-year survival rate after diagnosis of all types of lung cancer in Europe is 13% (11.2% for men and 13.9% for women). The five-year survival rate for some types of lung cancer ranges from 6% to 7% (small cell LC) and 23% to 28% for non-small cell lung cancer (NSCLC).
Currently there are important deficiencies when it comes to achieving an adequate lung cancer screening program. According to principles established in 1968, a screening program should be based on pathology that can be improved through the use of population screening.
The evidence suggests two important gaps in early detection. On the one hand, the identification of risk factors beyond smoking and age. And on the other hand, the only tool for early detection that has been shown to reduce morbidity and mortality in lung cancer is chest CT, a test that may not be sustainable in the long term for many healthcare systems. In parallel, lung cancer diagnoses among never smokers and reduced smokers are increasing rapidly, suggesting that if lung cancer screening research continues focusing only on the heaviest smokers, a gap will persist between the population that performs the test and the population that suffers from the disease.
Evidence also suggests that people undergoing screening are not being optimally referred for follow-up or kept engaged in long-term screening.
Currently there are important deficiencies when it comes to achieving an adequate lung cancer screening program. The incidence in individuals without a history of smoking is increasingly higher. Therefore, an observational, longitudinal, multicenter cohort analytical study will be conducted to determine eligibility for screening based on individualized risk (based on age, a more detailed smoking history, occupational exposure, and other risk factors such as ethnicity and family history of lung cancer) and the development and validation of lung cancer risk predictive models that can improve screening efficiency and reduce lung cancer morbidity and mortality.
These models will allow new clinical pathways and diagnostic workflow to be implemented to ensure rapid diagnosis and confirmation, including lung cancer subtype classification.
The study consists of collecting data from participants in 4 visits over two years. During each visit, the clinical evaluation will be carried out, which will consist of the collection of sociodemographic data and clinical history, physical examination, concomitant medication, collection of exposure data and guide symptoms, Quality of Life questionnaires and geolocation. In addition, the following tests will be performed: low-dose computed tomography (LDCT), blood tests, genomic analysis and tests with new non-invasive devices (spectrometry on card (SPOC), breath analyzer (BAN) and broad-spectrum biomarker sensor patch (WBSP)). With all this, the aim is to develop and validate new tests based on new non-invasive and easy-to-use technologies that allow for the implementation of more efficient, acceptable and equitable population screening programs in the near future.
The completion of this project will allow to provide data that can be used to better understand and discover new risk factors for suffering from lung cancer and therefore improve the management of the disease.
Furthermore, this study will favor the reduction of long-term morbidity and mortality from lung cancer and will allow the future implementation of a lung cancer program.
Первичные конечные точки
- presence of pulmonary nodules [Срок оценки: 2 years]
- Lung Cancer diagnosis [Срок оценки: 2 years]
Вторичные конечные точки (12)
- Age [Срок оценки: 2 years]
- Gender [Срок оценки: 2 years]
- Ethnicity [Срок оценки: 2 years]
- Socioeconomic factors [Срок оценки: 2 years]
- Education level [Срок оценки: 2 years]
- height [Срок оценки: 2 years]
- weight [Срок оценки: 2 years]
- Body Mass Index [Срок оценки: 2 years]
- Blood pressure [Срок оценки: 2 years]
- heart rate [Срок оценки: 2 years]
- respiratory rate [Срок оценки: 2 years]
- Global Initiative for Obstructive Lung Disease (GOLD) classification [Срок оценки: 2 years]
Критерии участия
Inclusion Criteria (for the 3 phases):
- Subjects aged between 40 and 80 years
- Both genders, of which at least 37% must be women to ensure representativeness
- Willingness and ability to comply with scheduled visits, laboratory tests, and other trial procedures
- Written informed consent obtained prior to performing any protocol-related procedures.
Inclusion criteria for Phase 2: Precision Screening:
- High risk of developing Lung Cancer volunteers will be selected by Lung Cancer risk factors modelling.
Inclusion criteria for Phase 3: Diagnosis:
\- Patients diagnosed with indeterminate pulmonary nodules or Lung Cancer from the screening phases.
Критерии исключения
- Subjects under 40 years of age
- Unable to be followed-up for at least 2-years or complete the study
- Subjects that do not sign the informed consent
- Current or prior history of lung cancer
- History of neoplasia in the previous 5 years except non-melanoma skin cancer
- Moderate-severe comorbidities that prevent completion of a diagnostic study in the event of findings suggestive of lung neoplasia (by means of the investigator's clinical judgment) or surgical intervention (< 6 months) if not previously confirmed by cytohistology.
- Vulnerable subjects: severe psychiatric comorbidity, adults under guardianship or deprived of liberty
- Pregnant women
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Испания · 3 центра
- Hospital Universitario Cruces — Barakaldo
- Hospital Universitario Virgen Macarena — Seville
- Aljarafe-Sevilla Norte Health District — Seville
Бельгия · 1 центр
- Centre Hospitalier Universitaire de Liège — Liège
Латвия · 1 центр
- Riga East University Hospital — Riga
Публикации
- van Meerbeeck JP, Franck C. Lung cancer screening in Europe: where are we in 2021? Transl Lung Cancer Res. 2021 May;10(5):2407-2417. doi: 10.21037/tlcr-20-890. PMID 34164288
- Oudkerk M, Liu S, Heuvelmans MA, Walter JE, Field JK. Lung cancer LDCT screening and mortality reduction - evidence, pitfalls and future perspectives. Nat Rev Clin Oncol. 2021 Mar;18(3):135-151. doi: 10.1038/s41571-020-00432-6. Epub 2020 Oct 12. PMID 33046839
- Adams SJ, Stone E, Baldwin DR, Vliegenthart R, Lee P, Fintelmann FJ. Lung cancer screening. Lancet. 2023 Feb 4;401(10374):390-408. doi: 10.1016/S0140-6736(22)01694-4. Epub 2022 Dec 20. PMID 36563698
- Gomez-Carballo N, Fernandez-Soberon S, Rejas-Gutierrez J. Cost-effectiveness analysis of a lung cancer screening programme in Spain. Eur J Cancer Prev. 2022 May 1;31(3):235-244. doi: 10.1097/CEJ.0000000000000700. PMID 34406177
- Thandra KC, Barsouk A, Saginala K, Aluru JS, Barsouk A. Epidemiology of lung cancer. Contemp Oncol (Pozn). 2021;25(1):45-52. doi: 10.5114/wo.2021.103829. Epub 2021 Feb 23. PMID 33911981
- Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer. Cancer Epidemiol Biomarkers Prev. 2019 Oct;28(10):1563-1579. doi: 10.1158/1055-9965.EPI-19-0221. PMID 31575553
- Zhang T, Joubert P, Ansari-Pour N, Zhao W, Hoang PH, Lokanga R, Moye AL, Rosenbaum J, Gonzalez-Perez A, Martinez-Jimenez F, Castro A, Muscarella LA, Hofman P, Consonni D, Pesatori AC, Kebede M, Li M, Gould Rothberg BE, Peneva I, Schabath MB, Poeta ML, Costantini M, Hirsch D, Heselmeyer-Haddad K, Hutchinson A, Olanich M, Lawrence SM, Lenz P, Duggan M, Bhawsar PMS, Sang J, Kim J, Mendoza L, Saini N, PMID 34493867
- Ramaswamy A. Lung Cancer Screening: Review and 2021 Update. Curr Pulmonol Rep. 2022;11(1):15-28. doi: 10.1007/s13665-021-00283-1. Epub 2022 Apr 2. PMID 35402145
Идентификаторы
NCT: NCT06473870 · LUCIA