NCT07871656 · Thomas Jefferson University
Lung Cancer Detection in Never Smokers Using Urine Volatile Organic Compound (VOCs)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Sensitivity of the Biosensor Platform (BSP) for Detection of Lung Cancer in the Jefferson Health Cohort
Time frame: Up to 24 months
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.
Specificity of the Biosensor Platform (BSP) for Detection of Lung Cancer in the Jefferson Health Cohort
Time frame: Up to 24 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- Adults over 18 years of age. Participants must be legally competent to provide informed consent.
- 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.
- Neversmoking status, defined as \<100 lifetime cigarettes.
- Confirmed or pending clinical diagnosis of either benign or malignant lung lesions, based on radiological and/or histopathological evaluation performed as part of routine care.
- Able and willing to provide a urine sample of between 20 to 50 ml, collected in a sterile container under study supervision.
- Able to understand the study information and provide written informed consent after adequate explanation of the study purpose, procedures, data handling, and absence of direct clinical benefit
Exclusion criteria
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnant or breastfeeding women. Pregnancy may alter urinary metabolite composition, potentially affecting analytical accuracy.
- Patients with end-stage renal disease, defined as estimated glomerular filtration rate (eGFR) \<15mL/min/1.73m2 or the initiation of long-term dialysis or transplantation.
- Previous diagnosis or treatment for any type of cancer. Prior malignancy or cancer therapy (surgery, chemotherapy, radiotherapy, biologic or immunotherapy) could influence urinary volatile compound profiles and confound results.
- Active severe illness or other conditions that, in the opinion of the investigator, would interfere with participation or pose unnecessary risk.
- Sample quality or collection constraints. Participants who cannot provide a urine sample within the required time window or under appropriate conditions for freezing and shipment will be excluded.
Where
- Philadelphia, Pennsylvania
Collaborators
EARLY Labs
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 13, 2026 · Source of record for eligibility and locations