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Electronic Nose Technology for the Tracking of Treatment Response in Patients with Stage I-IIIB Non-small Cell Lung Cancer
Trial Status: active
This phase II trial studies the ability of a new technology called breathprinting, or electronic nose (E-Nose), to track response to standard treatment in patients with stage I-IIIB non-small cell lung cancer (NSCLC). The E-nose technology is a system of chemical sensors that act like a human nose to detect different chemicals in gases. The E-nose technology involves collecting a breath sample that is blown out (exhaled) into a pipe-like device (called the pneumopipe device). The pneumopipe device captures the breath in a cartridge so a laboratory can test the breath for certain chemicals that are found in people with NSCLC. E-Nose may be able to measure how patients respond to NSCLC treatments without the need for invasive procedures (like biopsy).
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
Eastern Cooperative Oncology Group (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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07218601.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Gaetano Rocco
Phone: 212-639-3478
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Gaetano Rocco
Phone: 212-639-3478
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Gaetano Rocco
Phone: 212-639-3478
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Gaetano Rocco
Phone: 212-639-3478
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Gaetano Rocco
Phone: 212-639-3478
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Gaetano Rocco
Phone: 212-639-3478
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Gaetano Rocco
Phone: 212-639-3478
PRIMARY OBJECTIVE:
I. Quantify the change in volatile organic compounds (VOCs) (obtained using E-nose technology) before and after neoadjuvant therapy among patients with and without major pathologic response (MPR) on pathologic analysis (Cohort 1: stages II to IIIB).
SECONDARY OBJECTIVES:
I. Quantify the change in VOCs before and after neoadjuvant therapy among patients with and without MPR on pathologic analysis, within the subset of patients who underwent complete resection (Cohort 1: stages II to IIIB with complete resection).
II. Quantify the change in VOCs before and after neoadjuvant therapy among patients with and without pathologic complete response (pCR) on pathologic analysis (Cohort 1: Stages II to IIIB).
III. Quantify the change in VOCs before and after neoadjuvant therapy among patients with and without pCR on pathologic analysis, within the subset of patients who underwent complete resection (Cohort 1: stages II to IIIB with complete resection).
IV. Assess the relationship between the change in VOCs (perioperative and during follow-up) and locoregional and/or distant progression for all resectable stages of disease (separate analyses for Cohort 1 [stage II to IIIB] and Cohort 2 [stage I]).
V. Assess the association between the change in VOCs detected on E-nose and response on imaging (according to Response Evaluation Criteria in Solid Tumors [RECIST], Cohort 1 [stage II to IIIB]) as well as the development of posttreatment progression (Cohort 1 [stage II to IIIB] and Cohort 2 [stage I]).
CORRELATIVE OBJECTIVE:
I. Assess the association between results from the E-nose and results from alternative approaches (circulating tumor deoxyribonucleic acid [ctDNA], serum protein biomarkers) and response to treatment (MPR and pCR among Cohort 1 [stages II to IIIB]) and disease progression (Cohort 1 [stage II to IIIB] and Cohort 2 [stage I]).
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT 1 (STAGE II-IIIB NSCLC): Patients undergo collection of breath samples using the E-Nose pneumopipe device over 3 minutes each at baseline, at 2 weeks after completion of standard neoadjuvant treatment, at 6 months after standard surgery, and then every 6 months for 2 years. Patients also undergo collection of blood samples throughout the study.
COHORT 2 (STAGE I NSCLC): Patients undergo collection of breath samples using the E-Nose pneumopipe device over 3 minutes each at baseline, at 2 weeks and 6 months after completion of standard surgery, and then every 6 months for 2 years. Patients also undergo collection of blood samples throughout the study.
After completion of study intervention, patients are followed every 6 months for 3 years.
Trial PhasePhase II
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
