Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
210 participants
OBSERVATIONAL
2023-08-24
2026-08-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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).
urine sample
urine sample will be collected
Interventions
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urine sample
urine sample will be collected
Eligibility Criteria
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Inclusion Criteria
°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
* 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)
18 Years
90 Years
ALL
Yes
Sponsors
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EARLY Labs
UNKNOWN
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Gaetano Rocco, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 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 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 Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States
Countries
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Central Contacts
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David Jones, MD
Role: CONTACT
Facility Contacts
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Gaetano Rocco, MD
Role: primary
Gaetano Rocco, MD
Role: primary
Gaetano Rocco, MD
Role: primary
Gaetano Rocco, MD
Role: primary
Gaetano Rocco, MD
Role: primary
Gaetano Rocco, MD
Role: primary
Gaetano Rocco, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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23-111
Identifier Type: -
Identifier Source: org_study_id
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