Using Urine Samples to Identify Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033248
• Other study ID #: 23-111
• Status: Recruiting
• Start date: August 24, 2023
• Est. completion date: August 2026

Study information

• Verified date: September 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Gaetano Rocco, MD
• Phone: 212-639-3478
• Email: roccog[@]mskcc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Phase I (with NSCLC): Aged 18 to 90 years with histologically proven, previously untreated stage I, II, or IIIA NSCLC

• 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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Diagnostic Test:
• urine sample
urine sample will be collected

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (All Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (All Protocol Activities)	Uniondale	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	EARLY Labs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detect the presence or absence of NSCLC-specific VOCs	in urine samples	2 years

External Links

•   Memorial Sloan Kettering Cancer Center