Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis

Pneumonitis Clinical Trial

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

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. ;

Related Conditions & MeSH terms

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

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