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
1 other identifier
observational
210
1 country
7
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2023
CompletedFirst Submitted
Initial submission to the registry
September 5, 2023
CompletedFirst Posted
Study publicly available on registry
September 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
July 20, 2025
July 1, 2025
2.9 years
September 5, 2023
July 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
detect the presence or absence of NSCLC-specific VOCs
in urine samples
2 years
Study Arms (1)
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
Eligibility Criteria
Thoracic Surgery clinics
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- EARLY Labscollaborator
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gaetano Rocco, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2023
First Posted
September 13, 2023
Study Start
August 24, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
July 20, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
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.