Using E-Nose Technology to Track Treatment Response in People With Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breath sample collection, Research blood collection.
- Who it may be relevant to
- Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Electronic Nose (E-nose) Technology to Assess Pathologic Response and Post- Treatment Progression for Non-small Cell Lung Cancer: a Phase II Study
Overview
The researchers are doing this study to test the ability of a new technology called breathprinting, or electronic nose (E-Nose), to measure changes in certain chemicals in the breath before and after standard neoadjuvant therapy in people with NSCLC.
Interventions
- Diagnostic test Breath sample collection
Cohort 1: patients undergoing neoadjuvant treatment (stages II to IIIB) will undergo breath sampling (1) at baseline before any treatment, (2) 2 weeks after neoadjuvant therapy, (3) 2 weeks after surgery, (4) 6 months after surgery, and (5) every 6 months for the first 2 years. Cohort 2: patients who are planned to undergo upfront surgery will undergo breath sampling (1) at baseline before upfront surgery, (2) 2 weeks after surgery, (3) 6 months after surgery, and (4) every 6 months for the fir - Diagnostic test Research blood collection
Cohort 1: Blood sample collections will coincide with the breath collection schedule.
Primary outcome measures
- pathological response (Cohort 1: stages II to IIIB) [Time frame: up to 2 years]
- progression (Cohort 1: stages II to IIIB) [Time frame: up to 2 years]
- progression (Cohort 2: Stage I) [Time frame: up to 2 years]
Eligibility criteria
Inclusion criteria
- Age ≥18
- Untreated clinical stage I NSCLC amenable to upfront surgery
- Untreated stage II to IIIB NSCLC amenable to neoadjuvant treatment followed by surgery
- ECOG Performance Status of ≤2 Of note, the E-nose is a completely noninvasive technology (only breath samples are collected). Therefore, this intervention would have no effects on a developing human fetus. There are therefore no requirements for the study population related to contraception or pregnancy testing.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 7 centers
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities) — Commack
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale
Identifiers
NCT: NCT07218601 · 25-124