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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether trained lab animals can find signs of non-small cell lung cancer (NSCLC) by smelling urine samples. It includes adults who have this cancer, may have it, or have not been diagnosed with or suspected of having it.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All groups: Be 18 to 90 years old.
  • Phase I, with cancer: Have stage I, II, or IIIA NSCLC confirmed by a tissue test, with no past treatment for it.
  • Phase I, with cancer: Have one lung lump on one side that is at least half solid on a chest CT scan. An MSK radiologist must confirm that it looks like cancer that started in the lung.
  • Phase I, without cancer: Report that you do not have NSCLC.
  • Phase II: Have possible stage I, II, or IIIA NSCLC based on CT or PET scans, but no diagnosis yet.

Who can't join

  • Be younger than 18.
  • Have no available low-dose CT scan results.
  • Have had any cancer treatment in the past year, such as radiation, chemotherapy, biological therapy, or surgery to remove cancer.
  • Be pregnant.
  • Take medicines that affect the immune system, which helps your body fight illness.
  • Have a long-term disease linked to the immune system.
  • Have missing medical details, such as the current cancer stage.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (7)

NJ

NY