Understanding Lung Cancer Related Risk Factors and Their Impact
- Conditions
- Lung Cancer Screening
- Registration Number
- NCT06473870
- Lead Sponsor
- Biocruces Bizkaia Health Research Institute
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 6160
Not provided
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Socioeconomic factors 2 years deprivation index
weight 2 years kilograms
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
Iron baseline μg/dL
Chloride baseline mEq/L
height 2 years meter
Body Mass Index 2 years kg/m\^2
heart rate 2 years beats/min
respiratory rate 2 years breaths/min
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).
Age 2 years years
Gender 2 years Male/female
Education level 2 years description of the education level
Forced Vital Capacity (FVC) 2 years mL, %, Lower limit of Normal and z-score
FEV1/FVC ratio 2 years percentage (%)
Transferrin Index baseline index
transferrin baseline mg/dL
Alkaline phosphatase baseline U/L
Sodium baseline mEq/L
partial thromboplastin time baseline seg
international normalized ratio (INR) baseline ratio
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 lifestyleFantastic 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 improvementThe 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
Glucose baseline mg/dL
HDL Cholesterol baseline mg/dL
Proteins baseline g/dL
GOT baseline U/L
potassium baseline mEq/L
carcinoembryonic antigen (CEA) baseline ng/mL
Neuronal specific enolase (NSE) baseline ng/mL
Ethnicity 2 years description of the ethnia
Blood pressure 2 years Systolic and diastolic blood pressure in mmHg
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.
Exploratory Omics markers baseline Dedicated blood samples will be specifically performed for a large Omics analysis.
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
Breath Analyzer (BAN) device 2 years Measurement of Volatile Organic Compounds (VOCs) of a breath sample for Lung Cancer early detection
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 Expiratory Volume in 1 second (FEV1) 2 years mL, %, Lower limit of Normal and z-score
Tumor pathology 2 years Tumor biopsy will be carried out in order to classify and characterize it regarding its size and location.
C reactive protein baseline mg/L
Albumin baseline g/dL
LDL Cholesterol baseline mg/dL
Lactate dehydrogenase baseline U/L
phosphate baseline mg/dL
urea baseline mg/dL
erythrocyte sedimentation rate baseline mm/h
Ferritin baseline ng/mL
Triglycerides baseline mg/dL
GPT baseline U/L
GGT baseline U/L
Creatinine baseline mg/dL
CA 125 baseline U/mL
CYFRA 21.1 baseline ng/mL
Complete blood count baseline number of blood cells, composition and percentage
fibrinogen baseline mg/dL
prothrombin time baseline seg
Geo location 2 years Participant's census tract identification (one for home address and one for workplace address)
Cholesterol baseline mg/dL
calcium baseline mg/dL
Bilirubin baseline mg/dL
Urate baseline mg/dL
Trial Locations
- Locations (5)
Aljarafe-Sevilla Norte Health District
🇪🇸Sevilla, Spain
Riga East University Hospital
🇱🇻Riga, Latvia
Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Wallonie, Belgium
Hospital Universitario Cruces
🇪🇸Barakaldo, Viscay, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain