This research is a clinical performance study of in vitro diagnostic device (IVD), a prospective, multicentre, open-label, case-control clinical investigation aimed at constructing a predictive model that allows results to be classified as positive or negative in relation to the probability of having lung cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,200
Peripheral blood samples will be collected to measure telomere-related biomarkers that will be used for the development of a predictive algorithm.
Laboratory analysis of telomere-associated biomarkers in blood samples to generate data for the development of a predictive clinical algorithm.
Hospital General Universitario de Elche
Elche, Alicante, Spain
RECRUITINGHospital del Mar
Barcelona, Barcelona, Spain
RECRUITINGInstitut Catalá D'Oncologia Badalona (ICO)
Barcelona, Barcelona, Spain
RECRUITINGHospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
RECRUITINGClínica Universidad de Navarra
Madrid, Madrid, Spain
RECRUITINGHM Sanchinarro/CIOCC
Madrid, Madrid, Spain
RECRUITINGHospital Universitario 12 Octubre
Madrid, Madrid, Spain
RECRUITINGHospital Universitario Clínico San Carlos
Madrid, Madrid, Spain
RECRUITINGHospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
RECRUITINGHospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
RECRUITING...and 2 more locations
To determine the risk of developing lung cancer, expressed as a percentage, in order to assist doctors in the diagnosis of lung cancer.
Time frame: At study enrollment
To evaluate the performance characteristics of the predictive algorithm, which combines clinical parameters and telomeric variables, in a cohort of cases and controls.
To determine the algorithm's ability to detect lung cancer by analysing its sensitivity, specificity, positive and negative predictive values, and overall accuracy.
Time frame: At study enrollment
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