Non Small Cell Lung CancerNCT06033248
Using Urine Samples to Identify Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- urine sample
- How many people
- 210 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 Aug 2023to Aug 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Thoracic Surgery clinics
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
David Jones, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Gaetano Rocco, MD, 212-639-3478
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
Commack, New York, 11725
Gaetano Rocco, MD, 212-639-3478
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Gaetano Rocco, MD, 212-639-3478
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Gaetano Rocco, MD, 212-639-3478
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Gaetano Rocco, MD, 212-639-3478
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Gaetano Rocco, MD, 212-639-3478
- Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
Gaetano Rocco, MD, 212-639-3478
About this study
Official title: 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).
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- urine sample
- Keywords
- Urine samples, stages I, II, and IIIA, 23-111
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine sampleDiagnostic test
urine sample will be collected
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
detect the presence or absence of NSCLC-specific VOCs
in urine samples
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start24 Aug 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- EARLY Labs
- Responsible party
- Sponsor
- Investigators
- Gaetano Rocco, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033248
- Sponsor's protocol ID
- 23-111
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.