Using Urine Samples to Identify Lung Cancer

Conditions

• Non Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Accepted

Interventions

• urine sample — DIAGNOSTIC_TEST
  urine sample will be collected

Study Details

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).

Key Dates

Start date

Aug 24, 2023

Status verified

Jul 2025

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

210 participants (estimated)

Arms

• Arm: 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).

Primary Outcome Measure

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

Central Contacts

• Gaetano Rocco, MD
  212-639-3478
  [email protected]
• David Jones, MD
  212-639-6428

Locations (7)

Find similar trials in Basking Ridge, NJ

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