Thomas Jefferson University
The goal of this observational study is to learn whether a urine-based test that measures volatile organic compounds (VOCs) can help detect lung cancer in people who have never smoked. The study will include adults who have never smoked, both with and without lung cancer. The main questions it aims to answer are: Can a urine VOC biosensor distinguish between people who have lung cancer and those who do not? Could this urine-based biomarker serve as a non-invasive approach for the early detection of lung cancer in people who are not currently eligible for standard lung cancer screening? Researchers will compare participants with lung cancer to participants without lung cancer to determine whether the urine VOC signature can identify differences between the two groups. Participants will: Provide a urine sample for VOC testing. Provide health and demographic information as required by the study. Be classified into groups based on whether they have been diagnosed with lung cancer.
Lung cancer is the leading cause of cancer deaths worldwide, and most lung cancers continue to be diagnosed at advanced stages of disease. Current methods for screening high-risk individuals with annual LDCT are insufficient, as evidenced by low rates of both screening eligibility and uptake. A non-invasive method for early detection is needed for populations currently excluded from screening. Although several blood-based biomarkers for lung cancer screening (LCS) are being tested in clinical trials enrolling LCS-eligible cohorts, there are no validated biomarkers for individuals who have neve…
Inclusion Criteria: * Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: 1. Adults over 18 years of age. Participants must be legally competent to provide informed consent. 2. Presence of a new, solid lung nodule identified on diagnostic CT chest scan ≥6mm in maximum diameter (representing indeterminate or suspicious nodules that may be due to a benign lung etiology or suspicious for primary lung cancer). If multiple lung nodules are present, the dominant lung nodule ≥6mm will be considered the index nodule. 3. Neversmokin…
The company developed a new system known as the "Biosensor Platform" (BSP). This platform integrates hardware, software, and database infrastructure designed by Early Labs. The outcomes are generated by a machine-learning algorithm powered by AI, which considers both the current and historical performance data of the biological sensors. Various controls are implemented to ensure the performance of the sensors is evaluated 100% of the time.
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