Using Urine Samples to Identify Lung Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06033248

Collaborator

EARLY Labs (Other)

210

Enrollment

Locations

35.3

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Diagnostic Test: urine sample

Study Design

Study Type:

Observational

Anticipated Enrollment :

210 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Actual Study Start Date :

Aug 24, 2023

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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).	Diagnostic Test: urine sample urine sample will be collected

Arm

Intervention/Treatment

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).

Diagnostic Test: urine sample

urine sample will be collected

Outcome Measures

Primary Outcome Measures

detect the presence or absence of NSCLC-specific VOCs [2 years]
in urine samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (All Protocol Activities)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (All Protocol Activities)	Uniondale	New York	United States	11553