An observational study in Lung Cancer, sponsored by Thomas Jefferson University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Thomas Jefferson University · Observational
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 never smoked. The investigators 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. The investigator 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.
7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's planned enrollment of 87 is below the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Thomas Jefferson University is the lead sponsor of 390 studies on the registry; 72 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 21 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Lung cancer cases will include patients with a specific malignant histopathology of primary lung cancer.
Diagnostic Test: Biosensor Platform
Non-cancer controls will include patients with a specific benign diagnosis (i.e. hamartoma, organizing pneumonia, granulomatous inflammation, infectious etiology with a specific organism on microbiologic studies) as well as nonspecific benign results (acute or chronic nonspecific inflammation or fibrosis).
Diagnostic Test: Biosensor Platform
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.
Also known as: BSP
Sensitivity of the Biosensor Platform (BSP) for Detection of Lung Cancer in the Jefferson Health Cohort
Percentage of participants with lung cancer who have positive Biosensor Platform (BSP) result. Sensitivity will be estimated using exact logistic regression and reported with 95% confidence interval.
Time frame: Up to 24 months
Specificity of the Biosensor Platform (BSP) for Detection of Lung Cancer in the Jefferson Health Cohort
Percentage of participants without lung cancer who have a negative Biosensor Platform (BSP) result. Specificity will be estimated using exact logistic regression and reported with 95% confidence interval.
Time frame: Up to 24 months
Sensitivity of the Biosensor Platform (BSP) for Detection of Lung Cancer in the Combined Jefferson Health Cohort and EARLY Labs Cohort
Percentage of participants with lung cancer who have positive Biosensor Platform (BSP) result. Sensitivity will be estimated using exact logistic regression and reported with 95% confidence interval.
Time frame: Up to 24 months
Specificity of the Biosensor Platform (BSP) for Detection of Lung Cancer in the Combined Jefferson Health Cohort and EARLY Labs Cohort
Percentage of participants without lung cancer who have a negative Biosensor Platform (BSP) result. Specificity will be estimated using exact logistic regression and reported with 95% confidence interval.
Time frame: Up to 24 months
Started Sep 2026 (actual). Primary completion is estimated for Mar 2028, 17 months after the start.
Of 578 non-industry observational studies under Lung Neoplasms, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 172. This study's planned 17 months is below that.
Counting every sponsor, half of 685 studies reached it within 56 months; a quarter within 29 and three quarters within 130.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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