Understanding Lung Cancer Related Risk Factors and Their Impact
NCT Number: NCT06473870
Acronym: LUCIA
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Lung Cancer Screening
Sponsor: Biocruces Bizkaia Health Research Institute
Collaborators: Technion, Israel Institute of Technology|Centro Nacional de Análisis Genómico|Vicomtech|University of Latvia|Centre Hospitalier Universitaire de Liege|Andaluz Health Service|Nanose Medical Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 6160
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2027-12
Locations: Centre Hospitalier Universitaire de Liège, Liège, Wallonie, 4000, Belgium|Riga East University Hospital, Riga, LV-1038, Latvia|Hospital Universitario Cruces, Barakaldo, Viscay, 48903, Spain|Hospital Universitario Virgen Macarena, Sevilla, 41009, Spain|Aljarafe-Sevilla Norte Health District, Sevilla, Spain

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.

Primary Outcome Measures: presence of pulmonary nodules, The main variable is the presence of pulmonary nodules identified by Low Dose Computerized Tomography (LDCT), 2 years|Lung Cancer diagnosis, The main variable is the presence of Lung Cancer diagnosis identified by Low Dose Computerized Tomography (LDCT)., 2 years
Secondary Outcome Measures: Age, years, 2 years|Gender, Male/female, 2 years|Ethnicity, description of the ethnia, 2 years|Socioeconomic factors, deprivation index, 2 years|Education level, description of the education level, 2 years|height, meter, 2 years|weight, kilograms, 2 years|Body Mass Index, kg/m\^2, 2 years|Blood pressure, Systolic and diastolic blood pressure in mmHg, 2 years|heart rate, beats/min, 2 years|respiratory rate, breaths/min, 2 years|Global Initiative for Obstructive Lung Disease (GOLD) classification, 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., 2 years|Medical record, 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., 2 years|Exposure to harmful agents, 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)., 2 years|Exploratory Omics markers, Dedicated blood samples will be specifically performed for a large Omics analysis., baseline|HEALTH-PROMOTING LIFESTYLE PROFILE II questionnaire (HPLP II), 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, 2 years|Fantastic lifestyle Checklist, 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, 2 years|Mediterranean diet adherence questionnaire, 0-14 points scale \<9 points --\> low adherence to Mediterranean diet \>9 points --\> High adherence to Mediterranean diet, 2 years|EuroQoL-5D-5L questionnaire, Scoring from 0-100 points. 0 points low quality of life 100 high quality of life, 2 years|The Alcohol Use Disorders Identification Test (AUDIT) questionnaire, 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, 2 years|Breath Analyzer (BAN) device, Measurement of Volatile Organic Compounds (VOCs) of a breath sample for Lung Cancer early detection, 2 years|Wide-biomarker-spectrum Multi-Use Sensing Patch (WBSP), Measurement of Volatile Organic Compounds (VOCs) in the sweat and skin headspace for Lung Cancer early detection, 2 years|Spectrometry-on-Card (SPOC), Measurement of biomarkers and signals from a blood sample for the early detection of lung cancer, 2 years|Tumor pathology, Tumor biopsy will be carried out in order to classify and characterize it regarding its size and location., 2 years|Lung CT scan description, 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., 2 years|Forced Vital Capacity (FVC), mL, %, Lower limit of Normal and z-score, 2 years|Forced Expiratory Volume in 1 second (FEV1), mL, %, Lower limit of Normal and z-score, 2 years|FEV1/FVC ratio, percentage (%), 2 years|Glucose, mg/dL, baseline|HDL Cholesterol, mg/dL, baseline|Iron, μg/dL, baseline|C reactive protein, mg/L, baseline|Proteins, g/dL, baseline|Albumin, g/dL, baseline|LDL Cholesterol, mg/dL, baseline|Ferritin, ng/mL, baseline|Chloride, mEq/L, baseline|Lactate dehydrogenase, U/L, baseline|Triglycerides, mg/dL, baseline|Transferrin Index, index, baseline|Cholesterol, mg/dL, baseline|transferrin, mg/dL, baseline|phosphate, mg/dL, baseline|calcium, mg/dL, baseline|GOT, U/L, baseline|GPT, U/L, baseline|GGT, U/L, baseline|Bilirubin, mg/dL, baseline|Alkaline phosphatase, U/L, baseline|urea, mg/dL, baseline|Creatinine, mg/dL, baseline|Sodium, mEq/L, baseline|potassium, mEq/L, baseline|Urate, mg/dL, baseline|carcinoembryonic antigen (CEA), ng/mL, baseline|CA 125, U/mL, baseline|CYFRA 21.1, ng/mL, baseline|Neuronal specific enolase (NSE), ng/mL, baseline|Complete blood count, number of blood cells, composition and percentage, baseline|erythrocyte sedimentation rate, mm/h, baseline|partial thromboplastin time, seg, baseline|fibrinogen, mg/dL, baseline|international normalized ratio (INR), ratio, baseline|prothrombin time, seg, baseline|Geo location, Participant's census tract identification (one for home address and one for workplace address), 2 years