Urine VOC Test to Detect Lung Cancer in Never Smokers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates whether a urine-based volatile organic compound biosensor can distinguish between never-smokers with and without lung cancer. Researchers collect urine samples and basic health and demographic information to compare VOC signatures across groups with confirmed or suspected lung lesions. The goal is to determine if this non-invasive biomarker could aid early detection in individuals not eligible for standard screening. Enrolled participants are adults without a smoking history who are undergoing evaluation for indeterminate pulmonary nodules and may be scheduled for biopsy or surgical resection. The study is conducted at Thomas Jefferson University with collaboration from EARLY Labs.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Julia A Barta, MD, ATSF — Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
• Study coordinator: Site Public Contact
• Email: ONCTrialNow@jefferson.edu
• Phone: 215-600-9151

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ePRO in advanced lung cancer: emotional distress, brain metastasis, and symptom burden

  This study tests how patients with advanced lung cancer—some with brain metastases—report emotional distress and symptoms over time using electronic questionnaires.

  Recruiting Tongji Hospital · Hubei, Wuhan · NCT07912190

• SI-B036 safety test in advanced and metastatic solid tumors

  This early-phase study checks whether SI-B036 is safe and tolerable in adults with advanced or metastatic solid cancers who have had prior therapy.

  Recruiting at 4 sites Phase 1 SystImmune Inc. · New Haven, Connecticut and 6 other locations · NCT07857616

• Guaraná Supplement for Cancer-Related Fatigue in People Undergoing Treatment

  This study tests whether taking guaraná capsules helps reduce cancer-related fatigue and improve quality of life in adults with breast, lung, colorectal, or gastric cancer who are actively receiving treatment.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá, Bogota D.C. · NCT07816263

• ENPP1/cGAS and FAP in Solid Tumors in Vietnamese Patients

  This Vietnam-based study will test ENPP1, cGAS, and FAP expression in archived tumor samples from Vietnamese adults with solid cancers using immunohistochemistry.

  Recruiting at 2 sites Tam Anh Research Institute · Hanoi, Hanoi and 1 other locations · NCT07808164

• Olive oil before lung cancer surgery to see if it lowers chylothorax

  This study tests whether drinking 40 mL of extra-virgin olive oil a few hours before lung cancer surgery can reduce chylothorax after tumor removal.

  Recruiting Fudan University · Shanghai, Xuhui · NCT07807696

• Multiomic analysis in relapsed small-cell lung cancer with DLL3 T cell engager

  This observational study tests how blood and tumor markers change over time in adults with relapsed small-cell lung cancer who are receiving a DLL3-targeted therapy, to see if those changes relate to clinical outcomes.

  Recruiting Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07795411

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.