Understanding Lung Cancer Related Risk Factors and Their Impact (LUCIA)

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.

Study Overview

Status

Not yet recruiting

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.

Study Type

Observational

Enrollment (Estimated)

6160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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)".

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of pulmonary nodules
Time Frame: 2 years
The main variable is the presence of pulmonary nodules identified by Low Dose Computerized Tomography (LDCT)
2 years
Lung Cancer diagnosis
Time Frame: 2 years
The main variable is the presence of Lung Cancer diagnosis identified by Low Dose Computerized Tomography (LDCT).
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: 2 years
years
2 years
Gender
Time Frame: 2 years
Male/female
2 years
Ethnicity
Time Frame: 2 years
description of the ethnia
2 years
Socioeconomic factors
Time Frame: 2 years
deprivation index
2 years
Education level
Time Frame: 2 years
description of the education level
2 years
height
Time Frame: 2 years
meter
2 years
weight
Time Frame: 2 years
kilograms
2 years
Body Mass Index
Time Frame: 2 years
kg/m^2
2 years
Blood pressure
Time Frame: 2 years
Systolic and diastolic blood pressure in mmHg
2 years
heart rate
Time Frame: 2 years
beats/min
2 years
respiratory rate
Time Frame: 2 years
breaths/min
2 years
Global Initiative for Obstructive Lung Disease (GOLD) classification
Time Frame: 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.
2 years
Medical record
Time Frame: 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.
2 years
Exposure to harmful agents
Time Frame: 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).
2 years
Exploratory Omics markers
Time Frame: baseline
Dedicated blood samples will be specifically performed for a large Omics analysis.
baseline
HEALTH-PROMOTING LIFESTYLE PROFILE II questionnaire (HPLP II)
Time Frame: 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

2 years
Fantastic lifestyle Checklist
Time Frame: 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

2 years
Mediterranean diet adherence questionnaire
Time Frame: 2 years
0-14 points scale <9 points --> low adherence to Mediterranean diet >9 points --> High adherence to Mediterranean diet
2 years
EuroQoL-5D-5L questionnaire
Time Frame: 2 years
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
Time Frame: 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
2 years
Breath Analyzer (BAN) device
Time Frame: 2 years
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)
Time Frame: 2 years
Measurement of Volatile Organic Compounds (VOCs) in the sweat and skin headspace for Lung Cancer early detection
2 years
Spectrometry-on-Card (SPOC)
Time Frame: 2 years
Measurement of biomarkers and signals from a blood sample for the early detection of lung cancer
2 years
Tumor pathology
Time Frame: 2 years
Tumor biopsy will be carried out in order to classify and characterize it regarding its size and location.
2 years
Lung CT scan description
Time Frame: 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.
2 years
Forced Vital Capacity (FVC)
Time Frame: 2 years
mL, %, Lower limit of Normal and z-score
2 years
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 2 years
mL, %, Lower limit of Normal and z-score
2 years
FEV1/FVC ratio
Time Frame: 2 years
percentage (%)
2 years
Glucose
Time Frame: baseline
mg/dL
baseline
HDL Cholesterol
Time Frame: baseline
mg/dL
baseline
Iron
Time Frame: baseline
μg/dL
baseline
C reactive protein
Time Frame: baseline
mg/L
baseline
Proteins
Time Frame: baseline
g/dL
baseline
Albumin
Time Frame: baseline
g/dL
baseline
LDL Cholesterol
Time Frame: baseline
mg/dL
baseline
Ferritin
Time Frame: baseline
ng/mL
baseline
Chloride
Time Frame: baseline
mEq/L
baseline
Lactate dehydrogenase
Time Frame: baseline
U/L
baseline
Triglycerides
Time Frame: baseline
mg/dL
baseline
Transferrin Index
Time Frame: baseline
index
baseline
Cholesterol
Time Frame: baseline
mg/dL
baseline
transferrin
Time Frame: baseline
mg/dL
baseline
phosphate
Time Frame: baseline
mg/dL
baseline
calcium
Time Frame: baseline
mg/dL
baseline
GOT
Time Frame: baseline
U/L
baseline
GPT
Time Frame: baseline
U/L
baseline
GGT
Time Frame: baseline
U/L
baseline
Bilirubin
Time Frame: baseline
mg/dL
baseline
Alkaline phosphatase
Time Frame: baseline
U/L
baseline
urea
Time Frame: baseline
mg/dL
baseline
Creatinine
Time Frame: baseline
mg/dL
baseline
Sodium
Time Frame: baseline
mEq/L
baseline
potassium
Time Frame: baseline
mEq/L
baseline
Urate
Time Frame: baseline
mg/dL
baseline
carcinoembryonic antigen (CEA)
Time Frame: baseline
ng/mL
baseline
CA 125
Time Frame: baseline
U/mL
baseline
CYFRA 21.1
Time Frame: baseline
ng/mL
baseline
Neuronal specific enolase (NSE)
Time Frame: baseline
ng/mL
baseline
Complete blood count
Time Frame: baseline
number of blood cells, composition and percentage
baseline
erythrocyte sedimentation rate
Time Frame: baseline
mm/h
baseline
partial thromboplastin time
Time Frame: baseline
seg
baseline
fibrinogen
Time Frame: baseline
mg/dL
baseline
international normalized ratio (INR)
Time Frame: baseline
ratio
baseline
prothrombin time
Time Frame: baseline
seg
baseline
Geo location
Time Frame: 2 years
Participant's census tract identification (one for home address and one for workplace address)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Julien Guiot, MD, Centre Hospitalier Universitaire de Liege
  • Principal Investigator: Luis G Luque-Romero, MD, Andaluz Health Service
  • Principal Investigator: David Vicente-Baz, MD, Andaluz Health Service
  • Principal Investigator: Alvils Krams, MD, University of Latvia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 25, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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