Lung Cancer Detection in Never Smokers Using Urine Volatile Organic Compound (VOCs)

Summary

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.

Detailed Description

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 never smoked. We propose to test a VOC signature using a novel urine biosensor platform in a cohort of prospectively recruited patients who have never smoked, with and without lung cancer. Successful completion of the project would provide proof-of-concept in an independent cohort and propel this technology into future multi-center validation studies for lung cancer detection. We aim to apply this biomarker to ultimately advance screening opportunities for LCS-ineligible individuals, an understudied population with an urgent need for earlier diagnosis. Eighty-seven patients at least 18 years of age without a smoking history (defined as fewer than 100 lifetime cigarettes), undergoing evaluation for an indeterminate pulmonary nodule ≥6mm on CT chest and planned for a lung biopsy or surgical resection at TJU CC and MHD, without previous diagnosis of or treatment for any type of cancer. The overall objective of the proposed project is to test a VOC signature using a urine biosensor platform in a prospective case-control study of patients who have never smoked and with moderate-risk lung nodules. Primary: Determine test performance (sensitivity and specificity) in a case-control cohort. Secondary: Determine test performance (sensitivity and specificity) in a combined cohort of Jefferson Health patients (Objective 1) and EARLY Labs Biobank participants. Exploratory Objectives: 1) Identify test performance among high-risk subgroups based on clinical factors including age, gender, family history of lung cancer, adenocarcinoma histology. 2) Determine reclassification rate of moderate-risk lung nodules into high- vs. low-risk groups. 3) Assess whether the combination of BSP test result with clinical lung nodule risk prediction score improves predictive accuracy.

Eligibility Criteria

Interventions