Detecting lung cancer using urine samples
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
This study is testing whether a special animal-based tool can detect lung cancer by analyzing urine samples from people with and without the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06033248 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of an animal biosensor platform (ABP) in identifying non-small cell lung cancer (NSCLC) through urine samples. Participants will include individuals diagnosed with NSCLC, those suspected of having it, and those without any diagnosis or suspicion of lung cancer. The ABP utilizes trained laboratory animals to detect specific chemicals in urine that are indicative of lung cancer, potentially offering a non-invasive alternative to traditional diagnostic methods like biopsies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 90 with confirmed or suspected stage I, II, or IIIA non-small cell lung cancer.
Not a fit: Patients under 18 years old or those who have received prior cancer treatment in the last year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and more accessible method for early detection of lung cancer.
How similar studies have performed: While the use of biosensors for cancer detection is an emerging field, this specific approach using urine samples and trained animals is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Phase I (with NSCLC): Aged 18 to 90 years with histologically proven, previously untreated stage I, II, or IIIA NSCLC °Note: Single, monolateral nodule of at least 50% solid composition visible on a Chest CT scan that is suspicious for a primary neoplasm as confirmed by an official MSK radiologist read * 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)
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Gaetano Rocco, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Gaetano Rocco, MD
- Email: roccog@mskcc.org
- Phone: 212-639-3478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.