Study Using Blood Telomere Analysis to Help Diagnose Lung Cancer in Adults Aged 45 and Older

What this Trial Is About

Researchers are conducting a prospective, multicenter clinical performance study to evaluate a new in vitro diagnostic device that uses telomere measurement technology to help diagnose lung cancer. The study aims to build a predictive model that classifies results as positive or negative based on the likelihood of having lung cancer. This investigation includes both high-risk and low-risk control groups as well as patients with confirmed lung cancer to better understand the devices diagnostic potential. Participants will be grouped into cases with lung cancer and controls classified as high risk or low risk for lung cancer. The study involves collecting peripheral blood samples to analyze telomere-related biomarkers. These biomarkers, combined with clinical parameters, will be used to develop a predictive algorithm that aids doctors in diagnosing lung cancer. The study is open-label and non-randomized, taking place across multiple centers. Study participants will undergo blood sample collection at enrollment for telomere biomarker analysis. Researchers will assess the risk percentage of developing lung cancer and evaluate the performance of the predictive algorithm using the collected data. The primary outcome is determining lung cancer risk at enrollment, with secondary outcomes focusing on algorithm performance. The study involves adults aged 45 years and older and includes ongoing monitoring of participant health status as part of the diagnostic evaluation process.

Prospective Multicentre Study for the Application of Telomere Measurement Technology as a Tool for Lung Cancer Diagnosis