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NCT Number: NCT06033248

Using Urine Samples to Identify Lung Cancer

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).

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Urine sample

Diagnostic Test

urine sample will be collected

Primary outcomes

  1. detect the presence or absence of NSCLC-specific VOCs

    Time frame: 2 years

    in urine samples

Study contacts

Contact information is provided by the study sponsor or research team.

David Jones, MD

CONTACT

212-639-6428

Gaetano Rocco, MD

CONTACT

[email protected]

212-639-3478

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • EARLY Labs

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 13, 2023
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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