Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Nonsmall Cell Lung Cancer Stage III
Pneumonia
Pneumonitis

Clinical Trial Details

NCT number	NCT04040244
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Terminated
Phase	N/A
Start date	December 9, 2019
Completion date	March 10, 2022

View Details

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