NCT07465848 Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis
| NCT ID | NCT07465848 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Grupo Español de Investigación en Diagnóstico y Tratamiento Hipertemprano de Enfermedades (GeDiTPhe) |
| Condition | Lung Cancer (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2025-10-08 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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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.
Eligibility Criteria
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
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