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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06033248
Other study ID # 23-111
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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