Trials / Terminated
TerminatedNCT04040244
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
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
| OTHER | Blood sample | Blood samples collected simultaneously with routine standard of care blood draws. |
Timeline
- Start date
- 2019-12-09
- Primary completion
- 2022-03-10
- Completion
- 2022-03-10
- First posted
- 2019-07-31
- Last updated
- 2023-10-11
- Results posted
- 2023-10-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04040244. Inclusion in this directory is not an endorsement.