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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06033248

Enrollment

210

Registered

2023-09-13

Start date

2023-08-24

Completion date

2027-08-01

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

Urine samples, stages I, II, and IIIA, 23-111

Brief 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).

Interventions

DIAGNOSTIC_TESTurine sample

urine sample will be collected

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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)

Design outcomes

Primary

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

Countries

United States

Contacts

CONTACTGaetano Rocco, MD

roccog@mskcc.org212-639-3478

CONTACTDavid Jones, MD

212-639-6428

PRINCIPAL_INVESTIGATORGaetano Rocco, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026