Using E-Nose Technology to Track Treatment Response in People With Non-Small Cell Lung Cancer

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07218601
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Breath sample collection — DIAGNOSTIC_TEST
    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 first 2 years.
  • Research blood collection — DIAGNOSTIC_TEST
    Cohort 1: Blood sample collections will coincide with the breath collection schedule.

Study Details

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.

Key Dates

Start date
Oct 10, 2025
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cohort 1 (stage II to IIIB NSCLC)
    45 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. Blood sample collections will coincide with the breath collection schedule.
  • Experimental: Cohort 2 (stage I NSCLC)
    15 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 first 2 years.

Primary Outcome Measure

pathological response (Cohort 1: stages II to IIIB) [ Time Frame: up to 2 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920
Gaetano Rocco, MD
212-639-3478
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748
Gaetano Rocco, MD
212-639-3478
Memorial Sloan Kettering Bergen (All Protocol Activities)MontvaleNew Jersey07645
Gaetano Rocco, MD
212-639-3478
Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)CommackNew York11725
Gaetano Rocco, MD
212-639-3478
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604
Gaetano Rocco, MD
212-639-3478
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Gaetano Rocco, MD
212-639-3478
Memorial Sloan Kettering Nassau (All Protocol Activities)UniondaleNew York11553
Gaetano Rocco, MD
212-639-3478

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