Lung CancerNCT07871656
Lung Cancer Detection in Never Smokers Using Urine Volatile Organic Compound (VOCs)
An observational study of Lung Cancer, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Biosensor Platform
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Julia A Barta, MD, ATSF, 215-600-9151, ONCTrialNow@jefferson.edu
About this study
Official title: Identification Of Lung Cancer In Never-Smoking Individuals Using A Non-Invasive Volatile Organic Compound (VOCs) Biological Platform With Urine Specimens
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:
Read more
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.
Read the 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. 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.
- Conditions
- Lung Cancer
- Being tested
- Biosensor Platform
- Keywords
- Smoking, Pulmonary Nodule, Lung Biopsy, Surgical Resection
- Medical subject headings
- Lung Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biosensor PlatformDiagnostic test
Also called BSP
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 group | Role | What they receive |
|---|---|---|
| Cohort 1: Lung Cancer Cases | Lung cancer cases will include patients with a specific malignant histopathology of primary lung cancer. Receives: Diagnostic Test: Biosensor Platform | |
| 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). Receives: Diagnostic Test: Biosensor Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 24 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start15 Sep 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- EARLY Labs
- Responsible party
- Sponsor
- Investigators
- Julia A Barta, MD, ATSF, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871656
- Sponsor's protocol ID
- 2026-0247
- Other IDs
- JT 48390
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification Of Lung Cancer In Never-Smoking Individuals Using A Non-Invasive Volatile Organic Compound (VOCs) Biological Platform With Urine Specimens
- ClinicalTrials.gov ID
- NCT07871656
- Acronym / sponsor ID
- 2026-0247
- Conditions
- Lung Cancer
- Keywords
- Smoking, Pulmonary Nodule, Lung Biopsy, Surgical Resection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- EARLY Labs
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Lung Cancer Cases | – | Diagnostic Test: Biosensor PlatformLung cancer cases will include patients with a specific malignant histopathology of primary lung cancer. |
| Cohort 2: Non-Cancer Controls | – | Diagnostic Test: Biosensor PlatformNon-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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
Key exclusion criteria (6 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biosensor PlatformAlso: BSPThe 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. | Diagnostic test | Cohort 1: Lung Cancer Cases, Cohort 2: Non-Cancer Controls |
Primary outcome
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.
2 secondary outcomes
Sensitivity of the Biosensor Platform (BSP) for Detection of Lung Cancer in the Combined Jefferson Health Cohort and EARLY Labs Cohort
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
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia A Barta, MD, ATSF principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Site Public Contact (215-600-9151, ONCTrialNow@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.