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Using Urine Samples to Identify Lung Cancer | Clinical Trials | Clareo Health

RECRUITING

Using Urine Samples to Identify Lung Cancer

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

NCT06033248•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Yes

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)

Locations (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States

Key Dates

Start Date

August 24, 2023

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2026

Last Updated

July 20, 2025

Enrollment

210

ESTIMATED participants

Conditions

Non Small Cell Lung Cancer

Interventions

urine sample

DIAGNOSTIC_TEST

Contacts

Gaetano Rocco, MD

CONTACT

212-639-3478 roccog@mskcc.org

David Jones, MD

CONTACT

212-639-6428

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Using Urine Samples to Identify Lung Cancer

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

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A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)