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
Location: See all (7) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• 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

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (All Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (All Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (All Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (All Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Gaetano Rocco, MD
roccog@mskcc.org
212-639-3478
Backup
David Jones, MD
212-639-6428
Time Frame
Start Date: 2023-08-24
Estimated Completion Date: 2026-08
Participants
Target number of participants: 210
Treatments
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).
Sponsors
Leads: Memorial Sloan Kettering Cancer Center
Collaborators: EARLY Labs

This content was sourced from clinicaltrials.gov

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