Using Urine Samples to Identify Lung Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Non Small Cell Lung Cancer

Treatments: Diagnostic Test: urine sample

Study type: Observational

Funder types: Other

Identifiers

NCT06033248

23-111

Details and patient eligibility

About

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).

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

210 participants in 1 patient group

patients diagnosed with NSCLC

Description:

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).

Treatment:

Diagnostic Test: urine sample