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.
Person aged 45 years or older at the time of signing the consent form.
Person with a current anatomopathologically confirmed diagnosis of small-cell or non-small cell lung cancer.
Not having received any oncological treatment prior to sample collection (surgery, radiotherapy, or systemic treatment with chemotherapy or immunotherapy).
Person aged 45 years or older at the time of signing the consent form.
History of any malignant neoplasm, except for subjects with tumors in localized stages who have undergone radical treatment and have been disease-free for at least five years.
Patient diagnosed with lung cancer who has already started oncological treatment before sample collection.
Patient who has undergone a biopsy or any invasive procedure or minor surgery less than 48 hours ago.
Patient who has undergone major surgery less than 7 days ago.
Parallel
Blood sample collection for telomere biomarker analysis
Diagnostic testPeripheral blood samples will be collected to measure telomere-related biomarkers that will be used for the development of a predictive algorithm.
Telomere biomarker analysis
Diagnostic testLaboratory analysis of telomere-associated biomarkers in blood samples to generate data for the development of a predictive clinical algorithm.
To determine the risk of developing lung cancer, expressed as a percentage, in order to assist doctors in the diagnosis of lung cancer.
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.
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Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe)
Lead sponsor
Life Length SL
Collaborator
Apices Soluciones S.L.
Collaborator
