Understanding Lung Cancer Related Risk Factors and Their Impact
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6,160
- 试验地点
- 5
- 主要终点
- presence of pulmonary nodules
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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
结局指标
主要结局
presence of pulmonary nodules
时间窗: 2 years
The main variable is the presence of pulmonary nodules identified by Low Dose Computerized Tomography (LDCT)
Lung Cancer diagnosis
时间窗: 2 years
The main variable is the presence of Lung Cancer diagnosis identified by Low Dose Computerized Tomography (LDCT).
次要结局
- heart rate(2 years)
- respiratory rate(2 years)
- Socioeconomic factors(2 years)
- weight(2 years)
- Wide-biomarker-spectrum Multi-Use Sensing Patch (WBSP)(2 years)
- Spectrometry-on-Card (SPOC)(2 years)
- Iron(baseline)
- Chloride(baseline)
- height(2 years)
- Body Mass Index(2 years)
- Medical record(2 years)
- Exposure to harmful agents(2 years)
- Age(2 years)
- Gender(2 years)
- Education level(2 years)
- Forced Vital Capacity (FVC)(2 years)
- FEV1/FVC ratio(2 years)
- Transferrin Index(baseline)
- transferrin(baseline)
- Alkaline phosphatase(baseline)
- Sodium(baseline)
- partial thromboplastin time(baseline)
- international normalized ratio (INR)(baseline)
- HEALTH-PROMOTING LIFESTYLE PROFILE II questionnaire (HPLP II)(2 years)
- Fantastic lifestyle Checklist(2 years)
- The Alcohol Use Disorders Identification Test (AUDIT) questionnaire(2 years)
- Glucose(baseline)
- HDL Cholesterol(baseline)
- Proteins(baseline)
- GOT(baseline)
- potassium(baseline)
- carcinoembryonic antigen (CEA)(baseline)
- Neuronal specific enolase (NSE)(baseline)
- Breath Analyzer (BAN) device(2 years)
- Ethnicity(2 years)
- Blood pressure(2 years)
- Global Initiative for Obstructive Lung Disease (GOLD) classification(2 years)
- Exploratory Omics markers(baseline)
- Mediterranean diet adherence questionnaire(2 years)
- EuroQoL-5D-5L questionnaire(2 years)
- Lung CT scan description(2 years)
- Forced Expiratory Volume in 1 second (FEV1)(2 years)
- Tumor pathology(2 years)
- C reactive protein(baseline)
- Albumin(baseline)
- LDL Cholesterol(baseline)
- Lactate dehydrogenase(baseline)
- phosphate(baseline)
- urea(baseline)
- erythrocyte sedimentation rate(baseline)
- Ferritin(baseline)
- Triglycerides(baseline)
- GPT(baseline)
- GGT(baseline)
- Creatinine(baseline)
- CA 125(baseline)
- CYFRA 21.1(baseline)
- Complete blood count(baseline)
- fibrinogen(baseline)
- prothrombin time(baseline)
- Geo location(2 years)
- Cholesterol(baseline)
- calcium(baseline)
- Bilirubin(baseline)
- Urate(baseline)