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

Identification Of Lung Cancer In Never-Smoking Individuals Using A Non-Invasive Volatile Organic Compound (VOCs) Biological Platform With Urine Specimens

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will: Provide a urine sample for VOC testing."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether chemicals in urine, called VOCs, can help find lung cancer in people who have never smoked. It is for adults with a new lung lump seen on a CT scan, with or without lung cancer. Researchers will compare urine samples from people with lung cancer and people without it.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18 and legally able to agree to join the study.
  • Have a new, solid lung nodule (a small lump) at least 6 mm wide on a chest CT scan. If there are several, the main lump must meet this size rule.
  • Have smoked fewer than 100 cigarettes in your lifetime.
  • Have a lung lump that is confirmed to be cancer or not cancer, or is still being checked through scans or tissue tests during regular care.
  • Be able and willing to give 20–50 mL of urine in a germ-free container while study staff supervise.
  • Understand the study and sign a consent form after learning about its purpose, steps, use of your data, and lack of direct health benefit.

Who can't join

  • Be pregnant or breastfeeding.
  • Have end-stage kidney disease: a kidney filtering rate (eGFR) below 15, or have started long-term dialysis or received a kidney transplant.
  • Have had a previous cancer diagnosis or treatment for any type of cancer.
  • Have a severe current illness or another condition that the study doctor thinks would make joining unsafe or difficult.
  • Be unable to give a urine sample within the required time or under the conditions needed for freezing and shipping.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: 1. Adults over 18 years of age. Participants must be legally competent to provide informed consent. 2. 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. 3. Neversmoking status, defined as \<100 lifetime cigarettes. 4. 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. 5. Able and willing to provide a urine sample of between 20 to 50 ml, collected in a sterile container under study supervision. 6. 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: 1. Pregnant or breastfeeding women. Pregnancy may alter urinary metabolite composition, potentially affecting analytical accuracy. 2. 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. 3. 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. 4. Active severe illness or other conditions that, in the opinion of the investigator, would interfere with participation or pose unnecessary risk. 5. 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.

Study sites (1)

PA