AzTrials
AzTrials

Lung Cancer ScreeningLUCIANCT06473870

Understanding Lung Cancer Related Risk Factors and Their Impact

An observational study of Lung Cancer Screening, run by Biobizkaia Health Research Institute at 5 sites in 3 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Lung Cancer Screening
How many people
6,160 participants
Where
5 sitesin 3 countries
Study dates
Jul 2024to Dec 2027
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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)".

Who may be able to join

  • 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.
  • High risk of developing Lung Cancer volunteers will be selected by Lung Cancer risk factors modelling.
  • Patients diagnosed with indeterminate pulmonary nodules or Lung Cancer from the screening phases.

Who cannot join

  • 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

Trial locations and contacts

5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Eunate Arana-Arri, PhD contact

+34 944881593 ext. 841593

eunate.aranaarri@osakidetza.eus

Jon E Idoyaga-Uribarrena, MPhar contact

+34 944881593 ext. 841593

joneneko.idoyagauribarrena@bio-bizkaia.eus

5 sites in 3 countries

Spain3 sites

  • Hospital Universitario Cruces

    Barakaldo, Viscay, 48903

    Eunate Arana-Arri, PhD, +34 944881593 ext. 841593, eunate.aranaarri@osakidetza.eus

    Jon E Idoyaga-Uribarrena, MPhar, +34 944881593 ext. 841593, joneneko.idoyagauribarrena@bio-bizkaia.eus

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    David Vicente-Baz, MD, david.vicente.sspa@juntadeandalucia.es

    Cristina Simarro, 650307416, cristinasimarro5@gmail.com

  • Aljarafe-Sevilla Norte Health District

    Seville

    Luis G Luque Romero, MD, luqueluis2@gmail.com

Other trials in Spain

Belgium1 site

  • Centre Hospitalier Universitaire de Liège

    Liège, Wallonia, 4000

    Julien Guiot, PhD, +32.4.284.49.01, j.guiot@chuliege.be

    Benoit Ernst, BA, benoit.ernst@uliege.be

Other trials in Belgium

Latvia1 site

  • Riga East University Hospital

    Riga, LV-1038

    Alvils Krams, MD, Alvils.Krams@aslimnica.lv

    Ilmārs Stonāns, PhD, + 371 28655158, ilmars.stonans@lu.lv

Other trials in Latvia

About this study

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.

Read the 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.

Keywords
Lung Cancer, Lung cancer screening, LDCT, Risk factors
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06473870
Study groupRoleWhat they receive
Study populationAdult 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. presence of pulmonary nodules

    The main variable is the presence of pulmonary nodules identified by Low Dose Computerized Tomography (LDCT)

    Measured: 2 years

  2. Lung Cancer diagnosis

    The main variable is the presence of Lung Cancer diagnosis identified by Low Dose Computerized Tomography (LDCT).

    Measured: 2 years

Secondary outcomes (65)

  1. Age

    years

    Measured: 2 years

  2. Gender

    Male/female

    Measured: 2 years

  3. Ethnicity

    description of the ethnia

    Measured: 2 years

  4. Socioeconomic factors

    deprivation index

    Measured: 2 years

  5. Education level

    description of the education level

    Measured: 2 years

  6. height

    meter

    Measured: 2 years

  7. weight

    kilograms

    Measured: 2 years

  8. Body Mass Index

    kg/m^2

    Measured: 2 years

  9. Blood pressure

    Systolic and diastolic blood pressure in mmHg

    Measured: 2 years

  10. heart rate

    beats/min

    Measured: 2 years

  11. respiratory rate

    breaths/min

    Measured: 2 years

  12. 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.

    Measured: 2 years

  13. 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.

    Measured: 2 years

  14. 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).

    Measured: 2 years

  15. Exploratory Omics markers

    Dedicated blood samples will be specifically performed for a large Omics analysis.

    Measured: baseline

  16. 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

    Measured: 2 years

  17. 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

    Measured: 2 years

  18. Mediterranean diet adherence questionnaire

    0-14 points scale <9 points --> low adherence to Mediterranean diet >9 points --> High adherence to Mediterranean diet

    Measured: 2 years

  19. EuroQoL-5D-5L questionnaire

    Scoring from 0-100 points. 0 points low quality of life 100 high quality of life

    Measured: 2 years

  20. 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

    Measured: 2 years

  21. Breath Analyzer (BAN) device

    Measurement of Volatile Organic Compounds (VOCs) of a breath sample for Lung Cancer early detection

    Measured: 2 years

  22. 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

    Measured: 2 years

  23. Spectrometry-on-Card (SPOC)

    Measurement of biomarkers and signals from a blood sample for the early detection of lung cancer

    Measured: 2 years

  24. Tumor pathology

    Tumor biopsy will be carried out in order to classify and characterize it regarding its size and location.

    Measured: 2 years

  25. 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.

    Measured: 2 years

  26. Forced Vital Capacity (FVC)

    mL, %, Lower limit of Normal and z-score

    Measured: 2 years

  27. Forced Expiratory Volume in 1 second (FEV1)

    mL, %, Lower limit of Normal and z-score

    Measured: 2 years

  28. FEV1/FVC ratio

    percentage (%)

    Measured: 2 years

  29. Glucose

    mg/dL

    Measured: baseline

  30. HDL Cholesterol

    mg/dL

    Measured: baseline

  31. Iron

    μg/dL

    Measured: baseline

  32. C reactive protein

    mg/L

    Measured: baseline

  33. Proteins

    g/dL

    Measured: baseline

  34. Albumin

    g/dL

    Measured: baseline

  35. LDL Cholesterol

    mg/dL

    Measured: baseline

  36. Ferritin

    ng/mL

    Measured: baseline

  37. Chloride

    mEq/L

    Measured: baseline

  38. Lactate dehydrogenase

    U/L

    Measured: baseline

  39. Triglycerides

    mg/dL

    Measured: baseline

  40. Transferrin Index

    index

    Measured: baseline

  41. Cholesterol

    mg/dL

    Measured: baseline

  42. transferrin

    mg/dL

    Measured: baseline

  43. phosphate

    mg/dL

    Measured: baseline

  44. calcium

    mg/dL

    Measured: baseline

  45. GOT

    U/L

    Measured: baseline

  46. GPT

    U/L

    Measured: baseline

  47. GGT

    U/L

    Measured: baseline

  48. Bilirubin

    mg/dL

    Measured: baseline

  49. Alkaline phosphatase

    U/L

    Measured: baseline

  50. urea

    mg/dL

    Measured: baseline

  51. Creatinine

    mg/dL

    Measured: baseline

  52. Sodium

    mEq/L

    Measured: baseline

  53. potassium

    mEq/L

    Measured: baseline

  54. Urate

    mg/dL

    Measured: baseline

  55. carcinoembryonic antigen (CEA)

    ng/mL

    Measured: baseline

  56. CA 125

    U/mL

    Measured: baseline

  57. CYFRA 21.1

    ng/mL

    Measured: baseline

  58. Neuronal specific enolase (NSE)

    ng/mL

    Measured: baseline

  59. Complete blood count

    number of blood cells, composition and percentage

    Measured: baseline

  60. erythrocyte sedimentation rate

    mm/h

    Measured: baseline

  61. partial thromboplastin time

    seg

    Measured: baseline

  62. fibrinogen

    mg/dL

    Measured: baseline

  63. international normalized ratio (INR)

    ratio

    Measured: baseline

  64. prothrombin time

    seg

    Measured: baseline

  65. Geo location

    Participant's census tract identification (one for home address and one for workplace address)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2024
  2. Study startJul 2024 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,160 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06473870
Sponsor's protocol ID
LUCIA
Acronym
LUCIA
Status last verified
Jun 2024
First submitted
16 May 2024
Last updated
25 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • van Meerbeeck JP, Franck C. Lung cancer screening in Europe: where are we in 2021? Transl Lung Cancer Res. 2021 May;10(5):2407-2417. doi: 10.21037/tlcr-20-890.

    PubMed 34164288

  • Oudkerk M, Liu S, Heuvelmans MA, Walter JE, Field JK. Lung cancer LDCT screening and mortality reduction - evidence, pitfalls and future perspectives. Nat Rev Clin Oncol. 2021 Mar;18(3):135-151. doi: 10.1038/s41571-020-00432-6. Epub 2020 Oct 12.

    PubMed 33046839

  • Adams SJ, Stone E, Baldwin DR, Vliegenthart R, Lee P, Fintelmann FJ. Lung cancer screening. Lancet. 2023 Feb 4;401(10374):390-408. doi: 10.1016/S0140-6736(22)01694-4. Epub 2022 Dec 20.

    PubMed 36563698

  • Gomez-Carballo N, Fernandez-Soberon S, Rejas-Gutierrez J. Cost-effectiveness analysis of a lung cancer screening programme in Spain. Eur J Cancer Prev. 2022 May 1;31(3):235-244. doi: 10.1097/CEJ.0000000000000700.

    PubMed 34406177

  • Thandra KC, Barsouk A, Saginala K, Aluru JS, Barsouk A. Epidemiology of lung cancer. Contemp Oncol (Pozn). 2021;25(1):45-52. doi: 10.5114/wo.2021.103829. Epub 2021 Feb 23.

    PubMed 33911981

  • Schabath MB, Cote ML. Cancer Progress and Priorities: Lung Cancer. Cancer Epidemiol Biomarkers Prev. 2019 Oct;28(10):1563-1579. doi: 10.1158/1055-9965.EPI-19-0221.

    PubMed 31575553

  • Zhang T, Joubert P, Ansari-Pour N, Zhao W, Hoang PH, Lokanga R, Moye AL, Rosenbaum J, Gonzalez-Perez A, Martinez-Jimenez F, Castro A, Muscarella LA, Hofman P, Consonni D, Pesatori AC, Kebede M, Li M, Gould Rothberg BE, Peneva I, Schabath MB, Poeta ML, Costantini M, Hirsch D, Heselmeyer-Haddad K, Hutchinson A, Olanich M, Lawrence SM, Lenz P, Duggan M, Bhawsar PMS, Sang J, Kim J, Mendoza L, Saini N, Klimczak LJ, Islam SMA, Otlu B, Khandekar A, Cole N, Stewart DR, Choi J, Brown KM, Caporaso NE, Wilson SH, Pommier Y, Lan Q, Rothman N, Almeida JS, Carter H, Ried T, Kim CF, Lopez-Bigas N, Garcia-Closas M, Shi J, Bosse Y, Zhu B, Gordenin DA, Alexandrov LB, Chanock SJ, Wedge DC, Landi MT. Genomic and evolutionary classification of lung cancer in never smokers. Nat Genet. 2021 Sep;53(9):1348-1359. doi: 10.1038/s41588-021-00920-0. Epub 2021 Sep 6.

    PubMed 34493867

  • Ramaswamy A. Lung Cancer Screening: Review and 2021 Update. Curr Pulmonol Rep. 2022;11(1):15-28. doi: 10.1007/s13665-021-00283-1. Epub 2022 Apr 2.

    PubMed 35402145

  • Ten Haaf K, van der Aalst CM, de Koning HJ, Kaaks R, Tammemagi MC. Personalising lung cancer screening: An overview of risk-stratification opportunities and challenges. Int J Cancer. 2021 Jul 15;149(2):250-263. doi: 10.1002/ijc.33578. Epub 2021 May 3.

    PubMed 33783822

  • Berghmans T, Lievens Y, Aapro M, Baird AM, Beishon M, Calabrese F, Degi C, Delgado Bolton RC, Gaga M, Lovey J, Luciani A, Pereira P, Prosch H, Saar M, Shackcloth M, Tabak-Houwaard G, Costa A, Poortmans P. European Cancer Organisation Essential Requirements for Quality Cancer Care (ERQCC): Lung cancer. Lung Cancer. 2020 Dec;150:221-239. doi: 10.1016/j.lungcan.2020.08.017. Epub 2020 Sep 4.

    PubMed 33227525

  • Lemjabbar-Alaoui H, Hassan OU, Yang YW, Buchanan P. Lung cancer: Biology and treatment options. Biochim Biophys Acta. 2015 Dec;1856(2):189-210. doi: 10.1016/j.bbcan.2015.08.002. Epub 2015 Aug 19.

    PubMed 26297204

  • Nasim F, Sabath BF, Eapen GA. Lung Cancer. Med Clin North Am. 2019 May;103(3):463-473. doi: 10.1016/j.mcna.2018.12.006.

    PubMed 30955514

  • Nooreldeen R, Bach H. Current and Future Development in Lung Cancer Diagnosis. Int J Mol Sci. 2021 Aug 12;22(16):8661. doi: 10.3390/ijms22168661.

    PubMed 34445366

  • Liu Y, Pan IE, Tak HJ, Vlahos I, Volk R, Shih YT. Assessment of Uptake Appropriateness of Computed Tomography for Lung Cancer Screening According to Patients Meeting Eligibility Criteria of the US Preventive Services Task Force. JAMA Netw Open. 2022 Nov 1;5(11):e2243163. doi: 10.1001/jamanetworkopen.2022.43163.

    PubMed 36409492

  • Braithwaite D, Gould MK. Is Lung Cancer Screening Reaching the People Who Are Most Likely to Benefit? JAMA Netw Open. 2022 Nov 1;5(11):e2243171. doi: 10.1001/jamanetworkopen.2022.43171. No abstract available.

    PubMed 36409500

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer Screening, run by Biobizkaia Health Research Institute at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain, Belgium, Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eunate Arana-Arri, PhD (+34 944881593 ext. 841593, eunate.aranaarri@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

presence of pulmonary nodules (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06473870, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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