Lung Cancer Screening
Conditions
Keywords
Lung Cancer, Lung cancer screening, LDCT, Risk factors
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Study design
Eligibility
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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| presence of pulmonary nodules | 2 years | The main variable is the presence of pulmonary nodules identified by Low Dose Computerized Tomography (LDCT) |
| Lung Cancer diagnosis | 2 years | The main variable is the presence of Lung Cancer diagnosis identified by Low Dose Computerized Tomography (LDCT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ethnicity | 2 years | description of the ethnia |
| Socioeconomic factors | 2 years | deprivation index |
| Education level | 2 years | description of the education level |
| height | 2 years | meter |
| weight | 2 years | kilograms |
| Body Mass Index | 2 years | kg/m\^2 |
| Blood pressure | 2 years | Systolic and diastolic blood pressure in mmHg |
| heart rate | 2 years | beats/min |
| respiratory rate | 2 years | breaths/min |
| Global Initiative for Obstructive Lung Disease (GOLD) classification | 2 years | only for COPD patient classification. Grade: GOLD 1 to 4 (from GOLD 1 which means mild stage of COPD to GOLD 4 very severe stage of COPD) Exacerbation history: GOLD A, B or E (depending on exacerbations: Gold A id 0 or 1 moderate exacerbations (not leading to hospitalization) with mMRC 0-1 CAT\<10; GOLD B if 0 or 1 moderate exacerbations (not leading to hospitalization) with mMRC \>= 2 CAT \>=10 and GOLD E if 2 or more moderate exacerbations or 1 or more leading to hospitalization) with mMRC 0-1 CAT\<10. |
| Medical record | 2 years | Family history of lung cancer or other types of cancer, emphysema/ COPD (+ GOLD classification)/ asthma, Interstitial Lung Disease (interstitial patterns), bronchiectasis, arterial hypertension, dyslipidemia, previous acute myocardial infarction, vasculopathies and chronic treatment. |
| Exposure to harmful agents | 2 years | Smoking and occupational exposure (physical activity and frequency, alcohol intake, cigarette packets/year, age of smoking onset, time elapsed since last cigarette, occupational exposure to carcinogens). |
| Exploratory Omics markers | baseline | Dedicated blood samples will be specifically performed for a large Omics analysis. |
| HEALTH-PROMOTING LIFESTYLE PROFILE II questionnaire (HPLP II) | 2 years | A score for overall health-promoting lifestyle is obtained by calculating a mean of the individual's responses to all 52 items; six subscale scores are obtained similarly by calculating a mean of the responses to subscale items. The use of means rather than sums of scale items is recommended to retain the 1 to 4 metric of item responses and to allow meaningful comparisons of scores across subscales. Lower scores (1) mean lower engage in a health-promoting lifestyle Higher scores (4) mean higher engage in a health-promoting lifestyle |
| Fantastic lifestyle Checklist | 2 years | Evaluation of the population lifestyle: 85-100 points --\> Excellent 70-84 points --\> Very good 55-69 points --\> Good 35-54 points --\> Fair 0-34 points --\> needs improvement |
| Mediterranean diet adherence questionnaire | 2 years | 0-14 points scale \<9 points --\> low adherence to Mediterranean diet \>9 points --\> High adherence to Mediterranean diet |
| EuroQoL-5D-5L questionnaire | 2 years | Scoring from 0-100 points. 0 points low quality of life 100 high quality of life |
| The Alcohol Use Disorders Identification Test (AUDIT) questionnaire | 2 years | Scoring from 0-40 points \>8 points --\> indicators of hazardous and harmful alcohol use 8-15 points --\> simple advice focused on the reduction of hazardous drinking 16-19 points --\> brief counseling and continued monitoring \>20 points --\> warrant further diagnostic evaluationfor alcohol dependence |
| Breath Analyzer (BAN) device | 2 years | Measurement of Volatile Organic Compounds (VOCs) of a breath sample for Lung Cancer early detection |
| Wide-biomarker-spectrum Multi-Use Sensing Patch (WBSP) | 2 years | Measurement of Volatile Organic Compounds (VOCs) in the sweat and skin headspace for Lung Cancer early detection |
| Spectrometry-on-Card (SPOC) | 2 years | Measurement of biomarkers and signals from a blood sample for the early detection of lung cancer |
| Tumor pathology | 2 years | Tumor biopsy will be carried out in order to classify and characterize it regarding its size and location. |
| Lung CT scan description | 2 years | A lungCT scan will be performed to. Lung nodules and other findings (if any) will be reported in order to diagnose a lung cancer. If no anomalies are found, it will also be reported. |
| Forced Vital Capacity (FVC) | 2 years | mL, %, Lower limit of Normal and z-score |
| Forced Expiratory Volume in 1 second (FEV1) | 2 years | mL, %, Lower limit of Normal and z-score |
| FEV1/FVC ratio | 2 years | percentage (%) |
| Glucose | baseline | mg/dL |
| HDL Cholesterol | baseline | mg/dL |
| Iron | baseline | μg/dL |
| C reactive protein | baseline | mg/L |
| Proteins | baseline | g/dL |
| Albumin | baseline | g/dL |
| LDL Cholesterol | baseline | mg/dL |
| Ferritin | baseline | ng/mL |
| Chloride | baseline | mEq/L |
| Lactate dehydrogenase | baseline | U/L |
| Triglycerides | baseline | mg/dL |
| Transferrin Index | baseline | index |
| Cholesterol | baseline | mg/dL |
| transferrin | baseline | mg/dL |
| phosphate | baseline | mg/dL |
| calcium | baseline | mg/dL |
| GOT | baseline | U/L |
| GPT | baseline | U/L |
| GGT | baseline | U/L |
| Bilirubin | baseline | mg/dL |
| Alkaline phosphatase | baseline | U/L |
| urea | baseline | mg/dL |
| Creatinine | baseline | mg/dL |
| Sodium | baseline | mEq/L |
| potassium | baseline | mEq/L |
| Urate | baseline | mg/dL |
| carcinoembryonic antigen (CEA) | baseline | ng/mL |
| CA 125 | baseline | U/mL |
| CYFRA 21.1 | baseline | ng/mL |
| Neuronal specific enolase (NSE) | baseline | ng/mL |
| Age | 2 years | years |
| erythrocyte sedimentation rate | baseline | mm/h |
| partial thromboplastin time | baseline | seg |
| fibrinogen | baseline | mg/dL |
| international normalized ratio (INR) | baseline | ratio |
| prothrombin time | baseline | seg |
| Geo location | 2 years | Participant's census tract identification (one for home address and one for workplace address) |
| Complete blood count | baseline | number of blood cells, composition and percentage |
| Gender | 2 years | Male/female |
Countries
Belgium, Latvia, Spain