Using Up-front ctDNA Testing to Improve Lung Cancer Diagnosis and Care and Develop Support Models with Liquid Biopsy

What this Trial Is About

Researchers are studying lung cancer patients to improve diagnosis and monitoring using a blood test called liquid biopsy, which analyzes tumor markers, circulating tumor cells, and circulating tumor DNA ctDNA. This multicenter, prospective observational study aims to introduce up-front ctDNA analysis into routine diagnostic care for advanced lung cancer patients in the Southeast of the Netherlands. The study also seeks to develop and validate decision support models that predict imaging outcomes and patient survival, and to create a new test detecting PD-L1 expression on circulating tumor cells. The study involves collecting blood samples from patients suspected of lung cancer, with extra blood draws for those with advanced disease. These samples will be used to analyze ctDNA and tumor markers. The study will track how the introduction of ctDNA testing affects the number of tissue genetic tests performed and the time needed to make treatment decisions. Over up to three years, researchers will develop and validate models to support patient diagnosis and monitoring, including a test using super-resolution microscopy to detect PD-L1 on tumor cells. Participants will have blood drawn during routine visits, with up to 20 draws over a maximum of 36 months. Researchers will compare genetic information from blood tests to tissue analyses, measure how decision support models perform, and assess the timing of imaging and survival predictions. The study involves minimal risk from blood draws and aims to enhance personalized care by integrating new testing methods into clinical practice.

Implementation of Up-front ctDNA Into Lung Cancer Care and Development of Liquid Biopsy-based Decision Support Models - LM² Study