Using Urine Samples to Identify Lung Cancer

Study Overview
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Brief Summary
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The researchers are doing this study to test the ability of an animal biosensor platform (ABP) to detect NSCLC. Participants in this study will either be diagnosed with NSCLC, suspected to have NSCLC, or have not been diagnosed or suspected to have NSCLC. The ABP test uses laboratory animals that are trained to detect (by smell) different chemicals in urine. Studies show that people with lung cancer have unique chemicals in their urine that are not present in people without lung cancer, and researchers think these chemicals can be used to identify people with lung cancer without the need for invasive procedures (like biopsy).

Official Title
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Validation and Determination of Feasibility for Clinical Use of an Animal Biosensor Platform to Detect Non-Small Cell Lung Cancer-Specific Volatile Organic Compounds in Urine Samples

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Diagnostic Test: urine sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Phase I (with NSCLC): Aged 18 to 90 years with histologically proven, previously untreated stage I, II, or IIIA NSCLC Phase I (without NSCLC): Aged 18 to 90 years with patient confirmed absence of NSCLC Phase II: Aged 18 to 90 years with suspected but undiagnosed stage I, II, or IIIA NSCLC by CT and/or PET scan criteria Exclusion Criteria: Aged <18 years Lack of available results from low-dose CT Receipt of radiation, chemotherapy, biological therapy, resection, or any other treatment for any cancer in the previous year Pregnant (for women) Taking drugs that affect the immune system Chronic disease related to the immune system Missing clinical data (i.e., current clinical staging)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients diagnosed with NSCLC<br>In phase I, the researchers will assess the ability of a rat-based ABP to detect the presence or absence of NSCLC-specific VOCs in urine samples from subjects with and without NSCLC. In phase II, the researchers will assess the ability of the ABP to detect the presence of NSCLC-specific VOCs in urine samples from subjects with suspected but undiagnosed NSCLC (clinical stage I to IIIA). Urine samples will be collected from 50 patients diagnosed with NSCLC and from 50 subjects without NSCLC for phase I and from 110 patients with suspected but undiagnosed NSCLC for phase II (total number of subjects = 210). | Diagnostic Test: urine sample<br>* urine sample will be collected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detect the presence or absence of NSCLC-specific VOCs | in urine samples | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urine samples, stages I, II, and IIIA, 23-111