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Brief Title: Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis
Official Title: A Pilot Study of Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis After Chemoradiotherapy For Stage III Non-Small Cell Lung Cancer
Study ID: NCT04040244
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Name: Michael Farris, MD
Affiliation: Wake Forest University Health Sciences
Role: PRINCIPAL_INVESTIGATOR