Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis

Study Overview
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Brief Summary
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This is a prospective pilot study investigating exhaled breath condensate analyses to quantify the variability over time of various biomarkers associated with symptomatic pneumonitis.

Detailed Description
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Primary Objective: • To quantify the intra-person variability of concentrations of TGF-β1, IL-6, IL-1α, and IL-10 measured in exhaled breath condensate. Secondary Objectives: To examine the associations between differences in pre-treatment and post-treatment exhaled breath condensate concentrations of TGF-β1, IL-6, IL-1α, and IL-10 and the development of CTCAE grade 2+ symptomatic pneumonitis. To examine the associations between serum measures of TGF-β1, IL-6, IL-1α, and IL-10 and: Exhaled breath condensate measures of the same biomarkers, and The development of CTCAE grade 2+ symptomatic pneumonitis. To examine the association between microbiome signatures found in pre-treatment exhaled breath condensate and the development of CTCAE grade 2+ symptomatic pneumonitis.

Official Title
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A Pilot Study of Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis After Chemoradiotherapy For Stage III Non-Small Cell Lung Cancer

Conditions
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Pneumonitis, Nonsmall Cell Lung Cancer Stage III

Intervention / Treatment
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* Other: Exhaled Breath Collection
* Other: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18 years old. Clinically diagnosed or suspected Stage III non-small cell lung cancer to be treated with chemoradiotherapy as part of cancer treatment, as determined by the treating clinician. Plan for treatment with definitive radiotherapy (≥60 Gy) with concurrent chemotherapy at the discretion of the treating radiation and medical oncologists. Willing and able to tolerate exhaled breath collection. Able to provide informed consent. Exclusion Criteria: Systemic (oral, intravenous or intramuscular) corticosteroid use for any reason within 5 days of registration. Prior radiotherapy directed at the chest (thoracic inlet superiorly to diaphragm inferiorly). Any systemic antibiotic use within 2 weeks of registration.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exhaled Breath Analysis<br>Exhaled breathe condensate will be collected using R-tube and ReCIVA device over 5-10 minutes. | Other: Exhaled Breath Collection<br>* Exhaled breath condensate (EBC) and exhaled breath volatiles (EBV) samples will be obtained over 5-10 minutes using a one-time use R-tube apparatus.<br>Other: Blood sample<br>* Blood samples collected simultaneously with routine standard of care blood draws.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability of Biomarkers | Concentrations of TGF-β1, IL-6, IL-1α, and IL-10 (ng/mL) will be measured in exhaled breath condensate at baseline, at 2 weeks and after chemotherapy start and 6 weeks after chemotherapy start (the end of chemotherapy) and 1 month after completion of chemotherapy using a 2-tailed alpha of 0.05 with detectable standard deviation units from baseline to post treatment. | At baseline and one month after completion of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT | TGF-β1, IL-6, IL-1α, and IL-10 (ng/mL) measured in exhaled breath condensate to compare mean change levels from (baseline), at 2 weeks after CRT start, 6-weeks after CRT start (the end of CRT), and 1 month after completion of chemotherapy using t-tests comparing mean change levels in each marker. | One month after completion of chemotherapy |