Clinical trial NCT06473870: Understanding Lung Cancer Related Risk Factors and Their Impact
Official title: Understanding Lung Cancer Related Risk Factors and Their Impact
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer Screening
Keywords: Lung Cancer
Lung cancer screening
LDCT
Risk factors
Lead sponsor: Biocruces Bizkaia Health Research Institute
Sponsor class: OTHER_GOV
Collaborators: name: Technion, Israel Institute of Technology
name: Centro Nacional de Análisis Genómico
name: Vicomtech
name: University of Latvia
name: Centre Hospitalier Universitaire de Liege
name: Andaluz Health Service
name: Nanose Medical Ltd.
First posted: 2024-06-25
Enrollment: 6160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects (40 years old or higher), smokers and non-smokers, both women and men who have the capacity to comply with the study follow-up and sign the informed consent, will be recruited from "Servicio Andaluz de Salud" (SAS), "Osakidetza Servicio Vasco de Salud" (OSA), "Centre Hospitalier Universitaire de Liège" (CHUL) and "Centre for Tuberculosis and Lung Diseases (CTLD) of Riga East University Hospital (REUH)".

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.

Eligibility criteria: 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

Primary outcomes:
measure: presence of pulmonary nodules
timeFrame: 2 years
measure: Lung Cancer diagnosis
timeFrame: 2 years
Secondary outcomes:
measure: Age
timeFrame: 2 years
measure: Gender
timeFrame: 2 years
measure: Ethnicity
timeFrame: 2 years
measure: Socioeconomic factors
timeFrame: 2 years
measure: Education level
timeFrame: 2 years
measure: height
timeFrame: 2 years
measure: weight
timeFrame: 2 years
measure: Body Mass Index
timeFrame: 2 years
measure: Blood pressure
timeFrame: 2 years
measure: heart rate
timeFrame: 2 years
measure: respiratory rate
timeFrame: 2 years
measure: Global Initiative for Obstructive Lung Disease (GOLD) classification
timeFrame: 2 years
measure: Medical record
timeFrame: 2 years
measure: Exposure to harmful agents
timeFrame: 2 years
measure: Exploratory Omics markers
timeFrame: baseline
measure: HEALTH-PROMOTING LIFESTYLE PROFILE II questionnaire (HPLP II)
timeFrame: 2 years
measure: Fantastic lifestyle Checklist
timeFrame: 2 years
measure: Mediterranean diet adherence questionnaire
timeFrame: 2 years
measure: EuroQoL-5D-5L questionnaire
timeFrame: 2 years
measure: The Alcohol Use Disorders Identification Test (AUDIT) questionnaire
timeFrame: 2 years
measure: Breath Analyzer (BAN) device
timeFrame: 2 years
measure: Wide-biomarker-spectrum Multi-Use Sensing Patch (WBSP)
timeFrame: 2 years
measure: Spectrometry-on-Card (SPOC)
timeFrame: 2 years
measure: Tumor pathology
timeFrame: 2 years
measure: Lung CT scan description
timeFrame: 2 years
measure: Forced Vital Capacity (FVC)
timeFrame: 2 years
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 2 years
measure: FEV1/FVC ratio
timeFrame: 2 years
measure: Glucose
timeFrame: baseline
measure: HDL Cholesterol
timeFrame: baseline
measure: Iron
timeFrame: baseline
measure: C reactive protein
timeFrame: baseline
measure: Proteins
timeFrame: baseline
measure: Albumin
timeFrame: baseline
measure: LDL Cholesterol
timeFrame: baseline
measure: Ferritin
timeFrame: baseline
measure: Chloride
timeFrame: baseline
measure: Lactate dehydrogenase
timeFrame: baseline
measure: Triglycerides
timeFrame: baseline
measure: Transferrin Index
timeFrame: baseline
measure: Cholesterol
timeFrame: baseline
measure: transferrin
timeFrame: baseline
measure: phosphate
timeFrame: baseline
measure: calcium
timeFrame: baseline
measure: GOT
timeFrame: baseline
measure: GPT
timeFrame: baseline
measure: GGT
timeFrame: baseline
measure: Bilirubin
timeFrame: baseline
measure: Alkaline phosphatase
timeFrame: baseline
measure: urea
timeFrame: baseline
measure: Creatinine
timeFrame: baseline
measure: Sodium
timeFrame: baseline
measure: potassium
timeFrame: baseline
measure: Urate
timeFrame: baseline
measure: carcinoembryonic antigen (CEA)
timeFrame: baseline
measure: CA 125
timeFrame: baseline
measure: CYFRA 21.1
timeFrame: baseline
measure: Neuronal specific enolase (NSE)
timeFrame: baseline
measure: Complete blood count
timeFrame: baseline
measure: erythrocyte sedimentation rate
timeFrame: baseline
measure: partial thromboplastin time
timeFrame: baseline
measure: fibrinogen
timeFrame: baseline
measure: international normalized ratio (INR)
timeFrame: baseline
measure: prothrombin time
timeFrame: baseline
measure: Geo location
timeFrame: 2 years
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
state: Wallonie
city: Riga
country: Latvia
facility: Riga East University Hospital
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
state: Viscay
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Aljarafe-Sevilla Norte Health District
Study officials:
affiliation: Andaluz Health Service
name: Luis G Luque-Romero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Andaluz Health Service
name: David Vicente-Baz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Latvia
name: Alvils Krams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire de Liege
name: Julien Guiot, MD
role: PRINCIPAL_INVESTIGATOR
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