💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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