Health Adult Subjects, Lung Cancer (Diagnosis), Patient
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTBlood sample collection for telomere biomarker analysis
Peripheral blood samples will be collected to measure telomere-related biomarkers that will be used for the development of a predictive algorithm.
DIAGNOSTIC_TESTTelomere biomarker analysis
Laboratory analysis of telomere-associated biomarkers in blood samples to generate data for the development of a predictive clinical algorithm.
Sponsors
Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe)
Life Length SL
Apices Soluciones S.L.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Case Group: * 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). Control Group: Cohort A (High risk controls): * Person aged 45 years or older at the time of signing the consent form. * High risk of lung cancer, defined as having a smoking history of at least 20 pack-year and currently smoking or having quit within the past 15 years. * No diagnosis or suspicion of lung cancer. Asymptomatic individuals who have undergone a chest computed tomography (CT) scan for lung cancer screening within the 12 months prior to signing the informed consent and as part of routine clinical practice, with a LUNG-RADS score of 3 or lower, will be included. Cohort B (Low-risk controls): * Person aged 45 years or older at the time of signing the consent form. * Without high risk of lung cancer according to the criteria defined in cohort A. * No diagnosis or suspicion of lung cancer.
Exclusion criteria
* 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. * Patient with severe chronic kidney disease, defined as a glomerular filtration rate below 15 ml/min. * Patient with severe liver disease, defined as Child-Pugh C. * Active infection, or treated less than 4 weeks ago. * Vulnerable population, for example, minors, prisoners, pregnant women, adults physically or mentally incapable of giving consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the risk of developing lung cancer, expressed as a percentage, in order to assist doctors in the diagnosis of lung cancer. | At study enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the performance characteristics of the predictive algorithm, which combines clinical parameters and telomeric variables, in a cohort of cases and controls. | At study enrollment | To determine the algorithm's ability to detect lung cancer by analysing its sensitivity, specificity, positive and negative predictive values, and overall accuracy. |
Countries
Spain
Contacts
CONTACTAntonio Cubillo, MD
CONTACTPaloma Peinado, MD
Outcome results
None listed