Electronic nose (breathprint) to track treatment response in non-small cell lung cancer
Electronic Nose (E-nose) Technology to Assess Pathologic Response and Post- Treatment Progression for Non-small Cell Lung Cancer: a Phase II Study
This trial will test whether an electronic nose breath test can detect chemical changes in the breath of adults with non-small cell lung cancer before and after neoadjuvant therapy or surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT07218601 on ClinicalTrials.gov |
What this trial studies
This phase 2 interventional study collects breath samples (and optional research blood) to measure volatile chemical patterns using an electronic nose before and after standard neoadjuvant therapy or upfront surgery. Eligible participants include adults with untreated clinical stage I disease planned for surgery or stage II–IIIB disease planned for neoadjuvant therapy followed by surgery. Breathprints will be compared with clinical measures of treatment response such as imaging and surgical pathology to identify changes associated with therapy. The procedure is noninvasive and aims to find reproducible breath biomarkers that correlate with treatment effect.
Who should consider this trial
Good fit: Adults (≥18) with untreated clinical stage I NSCLC planned for upfront surgery or stage II–IIIB NSCLC planned for neoadjuvant therapy followed by surgery and an ECOG performance status of 0–2.
Not a fit: Patients who are not candidates for surgery or neoadjuvant therapy, who have other histologies of lung cancer, or who cannot attend the study sites are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could offer a simple, noninvasive breath test to monitor how well lung cancer treatment is working.
How similar studies have performed: Prior small studies of breathprint and electronic nose technologies have shown promising signals for detecting and monitoring lung cancer, but larger clinical validation remains limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Gaetano Rocco, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Gaetano Rocco, MD
- Email: roccog@mskcc.org
- Phone: 212-639-3478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.