Evaluating the FlowPath Lung Test for Non-invasive Detection of Early Lung Cancer in High-Risk Adults with Lung Nodules

What this Trial Is About

Researchers are evaluating the FlowPath Lung Test, a non-invasive flow cytometry diagnostic tool that analyzes sputum samples to detect early-stage lung cancer in high-risk adults. This study focuses on individuals aged 50 to 80 years who have lung nodules measuring greater than 6 mm and less than 30 mm in diameter, identified by low-dose computed tomography LDCT. The goal is to assess the tests sensitivity and specificity in detecting lung cancer in this population. Participants provide sputum samples for the FlowPath Lung Test within six weeks of their baseline CT scan showing lung nodules. The study includes standard medical treatment and follow-up care as per institutional protocols. The nodules considered are new, increasing, or stable for up to six months, with the most suspicious nodule sized within the specified range. The study follows participants for up to 24 months to monitor outcomes. During the study, participants undergo sputum sample collection and routine standard-of-care follow-up with their healthcare providers. Researchers evaluate the FlowPath Lung Tests ability to detect early-stage lung cancer using the baseline sputum sample and follow-up data over two years. Participants medical information related to their standard care is collected with consent, and safety monitoring is conducted throughout the study period, which lasts until July 2029.

Evaluate the Clinical Performance of the Flow Cytometry - FlowPath Lung Test as a Sensitive and Specific Non-invasive Diagnostic of Sputum Samples to Identify/Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, 6 to <30 mm in Diameter, Determined by LDCT.