Using Urine Samples to Identify Lung Cancer

July 18, 2025 updated by: Memorial Sloan Kettering Cancer Center

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: David Jones, MD
  • Phone Number: 212-639-6428

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
        • Contact:
          • Gaetano Rocco, MD
          • Phone Number: 212-639-3478
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All Protocol Activities)
        • Contact:
          • Gaetano Rocco, MD
          • Phone Number: 212-639-3478
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (All Protocol Activities)
        • Contact:
          • Gaetano Rocco, MD
          • Phone Number: 212-639-3478
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
        • Contact:
          • Gaetano Rocco, MD
          • Phone Number: 212-639-3478
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (All Protocol Activities)
        • Contact:
          • Gaetano Rocco, MD
          • Phone Number: 212-639-3478
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
        • Contact:
          • Gaetano Rocco, MD
          • Phone Number: 212-639-3478
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (All Protocol Activities)
        • Contact:
          • Gaetano Rocco, MD
          • Phone Number: 212-639-3478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Thoracic Surgery clinics

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients diagnosed with NSCLC
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
urine sample will be collected

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

EARLY Labs

Investigators

  • Principal Investigator: Gaetano Rocco, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 18, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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