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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT07871656
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biosensor Platform — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

First listed
Oct 13, 2026
Start date
Sep 15, 2026
Status verified
Oct 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
87 participants (estimated)

Arms

  • Arm: Cohort 1: Lung Cancer Cases
    Lung cancer cases will include patients with a specific malignant histopathology of primary lung cancer.
  • Arm: Cohort 2: Non-Cancer Controls
    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).

Primary Outcome Measure

Sensitivity of the Biosensor Platform (BSP) for Detection of Lung Cancer in the Jefferson Health Cohort [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Julia A Barta, MD, ATSF
[email protected]
215-600-9151

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Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University· Philadelphia, PA

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