NCT06473870

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.

Trial Health

67
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,160

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
3 countries

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jul 2024Dec 2027

First Submitted

Initial submission to the registry

May 16, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

3.4 years

First QC Date

May 16, 2024

Last Update Submit

June 19, 2024

Conditions

Lung Cancer Screening

Keywords

Lung CancerLung cancer screeningLDCTRisk factors

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (65)

  • Age

    2 years

  • Gender

    2 years

  • Ethnicity

    2 years

  • Socioeconomic factors

    2 years

  • Education level

    2 years

  • +60 more secondary outcomes

Study Arms (1)

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)".

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)".

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre Hospitalier Universitaire de Liège

Liège, Wallonia, 4000, Belgium

Location

Riga East University Hospital

Riga, LV-1038, Latvia

Location

Hospital Universitario Cruces

Barakaldo, Viscay, 48903, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Aljarafe-Sevilla Norte Health District

Seville, Spain

Location

Related Publications (25)

  • 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.

    PMID: 34164288BACKGROUND

  • 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.

    PMID: 33046839BACKGROUND

  • 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.

    PMID: 36563698BACKGROUND

  • 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.

    PMID: 34406177BACKGROUND

  • 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.

    PMID: 33911981BACKGROUND

  • 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.

    PMID: 31575553BACKGROUND

  • 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.

    PMID: 34493867BACKGROUND

  • 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.

    PMID: 35402145BACKGROUND

  • 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.

    PMID: 33783822BACKGROUND

  • 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.

    PMID: 33227525BACKGROUND

  • 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.

    PMID: 26297204BACKGROUND

  • 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.

    PMID: 30955514BACKGROUND

  • 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.

    PMID: 34445366BACKGROUND

  • 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.

    PMID: 36409492BACKGROUND

  • 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.

    PMID: 36409500BACKGROUND

  • Ten Haaf K, Jeon J, Tammemagi MC, Han SS, Kong CY, Plevritis SK, Feuer EJ, de Koning HJ, Steyerberg EW, Meza R. Risk prediction models for selection of lung cancer screening candidates: A retrospective validation study. PLoS Med. 2017 Apr 4;14(4):e1002277. doi: 10.1371/journal.pmed.1002277. eCollection 2017 Apr.

    PMID: 28376113BACKGROUND

  • Gould MK, Huang BZ, Tammemagi MC, Kinar Y, Shiff R. Machine Learning for Early Lung Cancer Identification Using Routine Clinical and Laboratory Data. Am J Respir Crit Care Med. 2021 Aug 15;204(4):445-453. doi: 10.1164/rccm.202007-2791OC.

    PMID: 33823116BACKGROUND

  • Yeh MC, Wang YH, Yang HC, Bai KJ, Wang HH, Li YJ. Artificial Intelligence-Based Prediction of Lung Cancer Risk Using Nonimaging Electronic Medical Records: Deep Learning Approach. J Med Internet Res. 2021 Aug 3;23(8):e26256. doi: 10.2196/26256.

    PMID: 34342588BACKGROUND

  • de Koning HJ, van der Aalst CM, de Jong PA, Scholten ET, Nackaerts K, Heuvelmans MA, Lammers JJ, Weenink C, Yousaf-Khan U, Horeweg N, van 't Westeinde S, Prokop M, Mali WP, Mohamed Hoesein FAA, van Ooijen PMA, Aerts JGJV, den Bakker MA, Thunnissen E, Verschakelen J, Vliegenthart R, Walter JE, Ten Haaf K, Groen HJM, Oudkerk M. Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial. N Engl J Med. 2020 Feb 6;382(6):503-513. doi: 10.1056/NEJMoa1911793. Epub 2020 Jan 29.

    PMID: 31995683BACKGROUND

  • US Preventive Services Task Force; Krist AH, Davidson KW, Mangione CM, Barry MJ, Cabana M, Caughey AB, Davis EM, Donahue KE, Doubeni CA, Kubik M, Landefeld CS, Li L, Ogedegbe G, Owens DK, Pbert L, Silverstein M, Stevermer J, Tseng CW, Wong JB. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021 Mar 9;325(10):962-970. doi: 10.1001/jama.2021.1117.

    PMID: 33687470BACKGROUND

  • Triplette M, Wenger DS, Shahrir S, Kross EK, Kava C, Phipps A, Hawes SE, Cole A, Snidarich M, Crothers K. Patient Identification of Lung Cancer Screening Follow-Up Recommendations and the Association with Adherence. Ann Am Thorac Soc. 2022 May;19(5):799-806. doi: 10.1513/AnnalsATS.202107-887OC.

    PMID: 34727513BACKGROUND

  • Lin Y, Fu M, Ding R, Inoue K, Jeon CY, Hsu W, Aberle DR, Prosper AE. Patient Adherence to Lung CT Screening Reporting & Data System-Recommended Screening Intervals in the United States: A Systematic Review and Meta-Analysis. J Thorac Oncol. 2022 Jan;17(1):38-55. doi: 10.1016/j.jtho.2021.09.013. Epub 2021 Oct 6.

    PMID: 34624528BACKGROUND

  • Rivera GA, Wakelee H. Lung Cancer in Never Smokers. Adv Exp Med Biol. 2016;893:43-57. doi: 10.1007/978-3-319-24223-1_3.

    PMID: 26667338BACKGROUND

  • Smith RJ, Vijayaharan T, Linehan V, Sun Z, Ein Yong JH, Harris S, Mariathas HH, Bhatia R. Efficacy of Risk Prediction Models and Thresholds to Select Patients for Lung Cancer Screening. Can Assoc Radiol J. 2022 Nov;73(4):672-679. doi: 10.1177/08465371221089899. Epub 2022 Apr 26.

    PMID: 35471946BACKGROUND

  • Tammemagi MC, Ten Haaf K, Toumazis I, Kong CY, Han SS, Jeon J, Commins J, Riley T, Meza R. Development and Validation of a Multivariable Lung Cancer Risk Prediction Model That Includes Low-Dose Computed Tomography Screening Results: A Secondary Analysis of Data From the National Lung Screening Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190204. doi: 10.1001/jamanetworkopen.2019.0204.

    PMID: 30821827BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for DNA extraction

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Julien Guiot, MD

    Centre Hospitalier Universitaire de Liege

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eunate Arana-Arri, PhD

CONTACT

+34 944881593eunate.aranaarri@osakidetza.eus

Jon E Idoyaga-Uribarrena, MPhar

CONTACT

+34 944881593joneneko.idoyagauribarrena@bio-bizkaia.eus

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2024

First Posted

June 25, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

LA(1)ES(3)BE(1)