Non-Small Cell Lung Cancer
Conditions
Keywords
E-Nose Technology, 25-124
Brief summary
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_TESTBreath 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_TESTResearch blood collection
Cohort 1: Blood sample collections will coincide with the breath collection schedule.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathological response (Cohort 1: stages II to IIIB) | up to 2 years | obtained using E-nose technology, all patients who have pre-neoadjuvant treatment E-nose testing, pre-surgery E-nose testing, 2 week post-surgery E-nose testing, and E-nose testing every 6 months for 2 years will be considered evaluable for the primary endpoint of Major Pathologic Response (MPR). Patients with MPR confirmed on pathologic analysis will be considered to have had an MPR, whereas all other evaluable patients will be considered to have not had an MPR, in accordance with the intention-to-treat analysis. |
| progression (Cohort 1: stages II to IIIB) | up to 2 years | Differences in VOC expression between time-point assessments will be calculated in terms of VOC percentage change from baseline to assess the magnitude of change among patients with and without progression, particularly at earlier time points. Here, progression is considered as a binary endpoint, where progression includes recurrence, disease progression, or death within 2 years. |
| progression (Cohort 2: Stage I) | up to 2 years | Differences in VOC expression between time-point assessments will be calculated in terms of VOC percentage change from baseline to assess the magnitude of change among patients with and without progression, particularly at earlier time points. Here, progression is considered as a binary endpoint, where progression includes recurrence, disease progression, or death within 2 years. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGaetano Rocco, MD
Memorial Sloan Kettering Cancer Center
CONTACTDavid Jones, MD
CONTACTGaetano Rocco, MD
Outcome results
None listed