TerminatedNCT04040244Updated Oct 11, 2023Results posted

Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis

An interventional study of Exhaled Breath Collection and Blood sample in Pneumonitis and Nonsmall Cell Lung Cancer Stage III, sponsored by Wake Forest University Health Sciences. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-11.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Diagnostic

Why this study was terminated

The PI is requesting this study to be closed due to the departure of the Co-PI who is an integral part of the study.

Phase: Not applicable
Study type: Interventional
Enrollment: 16
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 studied

Pneumonitis
Nonsmall Cell Lung Cancer Stage III

Browse trials for

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 16 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age greater than or equal to 18 years old.
Clinically diagnosed or suspected Stage III non-small cell lung cancer to be treated with chemoradiotherapy as part of cancer treatment, as determined by the treating clinician.
Plan for treatment with definitive radiotherapy (≥60 Gy) with concurrent chemotherapy at the discretion of the treating radiation and medical oncologists.
Willing and able to tolerate exhaled breath collection.
Able to provide informed consent.

Exclusion criteria

Exclusion Criteria:

Systemic (oral, intravenous or intramuscular) corticosteroid use for any reason within 5 days of registration.
Prior radiotherapy directed at the chest (thoracic inlet superiorly to diaphragm inferiorly).
Any systemic antibiotic use within 2 weeks of registration.

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 16 participants (actual)

Study arms

Experimental
Exhaled Breath Analysis
Exhaled breathe condensate will be collected using R-tube and ReCIVA device over 5-10 minutes.
Other: Exhaled Breath Collection · Other: Blood sample

Interventions

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

What researchers measure

Primary outcomes

Variability of Biomarkers
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.
Time frame: At baseline and one month after completion of chemotherapy

Secondary outcomes

Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT
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.
Time frame: One month after completion of chemotherapy

Results

Posted Oct 11, 2023

Participant flow

Participant flow — Overall Study
Milestone	Exhaled Breath Analysis
Started	16
Completed	16
Not completed	0

Outcome measures

PrimaryVariability of Biomarkers

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.

Time frame:: At baseline and one month after completion of chemotherapy
Reported as:: Mean · ng/mL

Variability of Biomarkers
ng/mL	Exhaled Breath Analysis
TGF-b1 baseline	87.84 ± 15.94
TGF-b1 1 month post CRT	100.47 ± 21.90
IL-6 baseline	5.39 ± 2.49
IL-6 1 month post CRT	6.96 ± 1.11
IL-10 baseline	136.91 ± 19.85
IL-10 1 month post CRT	151.07 ± 26.99
IL-1a baseline	2.41 ± 2.52
IL-1a 1 month post CRT	2.36 ± 9.72

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

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.

Time frame:: One month after completion of chemotherapy
Reported as:: Mean · ng/mL

Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT
ng/mL	Exhaled Breath Analysis
TGF-b1 mean diff	14.81 ± 18.17
IL-6 mean diff	1.03 ± 2.34
IL-10 mean diff	18.62 ± 24.15
IL-1a mean diff	2.36 ± 9.72

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Exhaled Breath Analysis	0/16 (0%)	1/16 (6.3%)	5/16 (31.3%)

Most frequent serious events

Most frequent serious events
Event	Exhaled Breath Analysis
HypotensionVascular disorders	1/16
Cardiac arrestCardiac disorders	1/16
Gastrointestional hemorrhageGastrointestinal disorders	1/16

Most frequent other events

Showing 10 of 17

Most frequent other events
Event	Exhaled Breath Analysis
DyspneaRespiratory, thoracic and mediastinal disorders	3/16
PneumonitisRespiratory, thoracic and mediastinal disorders	2/16
EsophagitisGastrointestinal disorders	2/16
Dry skinSkin and subcutaneous tissue disorders	2/16
EpistaxisRespiratory, thoracic and mediastinal disorders	2/16
DyspepsiaGastrointestinal disorders	2/16
FatigueGeneral disorders	2/16
DysphagiaGastrointestinal disorders	2/16
Chest wall painMusculoskeletal and connective tissue disorders	2/16
Cardiac disordersCardiac disorders	1/16

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Exhaled Breath Analysis
Mean	65.6 (53 to 85)

Sex: Female, Male
Sex: Female, Male(Participants)	Exhaled Breath Analysis
Female	4
Male	12

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Exhaled Breath Analysis
Hispanic or Latino	0
Not Hispanic or Latino	16
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Exhaled Breath Analysis
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	3
White	13
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Exhaled Breath Analysis
United States	16

Study locations

1 site

Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina 27157, United States

References and documents

Study documents

Protocol and statistical analysis plan · May 14, 2021
Informed consent form · Sep 20, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04040244
Lead sponsor: Wake Forest University Health Sciences
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Jul 31, 2019
Start date: Dec 9, 2019
Primary completion: Mar 10, 2022
Completion: Mar 10, 2022
Results posted: Oct 11, 2023
Last update: Oct 11, 2023

Study contacts

Michael Farris, MD

principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pneumonia→

Other studies from this sponsor

Wake Forest University Health Sciences

Start the discussion