Recruiting

Lung Cancer

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06033248

Conditions

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

urine sample

Study Details

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).

Conditions

Non Small Cell Lung Cancer

Study ID

NCT06033248

Start date

Aug 24, 2023

Status verified date

Jul, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

210 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Interventions

urine sample

urine sample will be collected

Primary outcome measure

  • detect the presence or absence of NSCLC-specific VOCs [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Gaetano Rocco, MD

212-639-3478roccog@mskcc.org

David Jones, MD

212-639-6428

Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Gaetano Rocco, MD

212-639-3478

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Gaetano Rocco, MD

212-639-3478

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Gaetano Rocco, MD

212-639-3478

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Gaetano Rocco, MD

212-639-3478

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Gaetano Rocco, MD

212-639-3478

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Gaetano Rocco, MD

212-639-3478

Memorial Sloan Kettering Nassau (All Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Gaetano Rocco, MD

212-639-3478

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-21.