Lung Cancer Clinical Trial
Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis
Summary
This is a prospective pilot study investigating exhaled breath condensate analyses to quantify the variability over time of various biomarkers associated with symptomatic pneumonitis.
Full Description
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.
Eligibility Criteria
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.
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There is 1 Location for this study
Winston-Salem North Carolina, 27157, United States
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