Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Infections

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Pneumonia

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Communicable Diseases

Respiratory Tract Infections

Carcinoma, Bronchogenic

Bronchial Neoplasms

Exhaled breathe condensate will be collected using R-tube and ReCIVA device over 5-10 minutes.

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.

Exhaled Breath Collection

Blood samples collected simultaneously with routine standard of care blood draws.

Blood sample

Michael Farris, MD

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

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.

Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis

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

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.

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.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Exhaled breathe condensate will be collected using R-tube and ReCIVA device over 5-10 minutes.

Exhaled Breath Collection: 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.

Blood sample: Blood samples collected simultaneously with routine standard of care blood draws.

Exhaled Breath Analysis

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study Coordinator

TGF-b1 baseline

TGF-b1 1 month post CRT

IL-6 baseline

IL-6 1 month post CRT

IL-10 baseline

IL-10 1 month post CRT

IL-1a baseline

IL-1a 1 month post CRT

9 have data at baseline; 6 have data at 1 month post CRT (chemo-radiation treatment)

Variability of Biomarkers

TGF-b1 mean diff

IL-6 mean diff

IL-10 mean diff

IL-1a mean diff

6 participants who had relevant data at both required time points

Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis	NCT04040244	Pneumonitis Nonsmall Cell L...	Exhaled Breath ... Blood sample	18 Years -	Wake Forest University Health Sciences
Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis	NCT04040244	Pneumonitis Nonsmall Cell L...	Exhaled Breath ... Blood sample	18 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for exhaled breath collection