Dysautonomia International

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

Purpose

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.

Condition

Non-Small Cell Lung Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Cohort 1 (stage II to IIIB NSCLC)	40 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.	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 first 2 years. Diagnostic Test: Research blood collection Cohort 1: Blood sample collections will coincide with the breath collection schedule.
Experimental Cohort 2 (stage I NSCLC)	10 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.	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 first 2 years.

Recruiting Locations

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge 5095409, New Jersey 5101760 07920