PneumonitisNCT04040244
Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis
A study testing Exhaled Breath Collection and Blood sample in people with Pneumonitis and Nonsmall Cell Lung Cancer Stage III, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonitis, Nonsmall Cell Lung Cancer Stage III
- What is being tested?
- Exhaled Breath Collection and Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2019to 10 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
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
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
- Pneumonitis, Nonsmall Cell Lung Cancer Stage III
- Being tested
- Exhaled Breath Collection, Blood sample
- Medical subject headings
- Pneumonia, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exhaled Breath CollectionOther
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 sampleOther
Blood samples collected simultaneously with routine standard of care blood draws.
| Study group | Role | What they receive |
|---|---|---|
| Exhaled Breath Analysis | Experimental | Exhaled breathe condensate will be collected using R-tube and ReCIVA device over 5-10 minutes. Receives: Other: Exhaled Breath Collection; Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and one month after completion of chemotherapy
Secondary outcomes (1)
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.
Measured: One month after completion of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start9 Dec 2019
- Primary completion10 Mar 2022
- Study completion10 Mar 2022
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PneumonitisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Farris, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040244
- Sponsor's protocol ID
- IRB00059924
- Other IDs
- WFBCCC 98119, NCI-2019-05682, P30CA012197
- Status last verified
- Aug 2023
- First submitted
- 29 Jul 2019
- Last updated
- 11 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04040244
- Acronym / sponsor ID
- IRB00059924
- Conditions
- Pneumonitis, Nonsmall Cell Lung Cancer Stage III
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Posted 11 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exhaled Breath Analysis | Experimental | Other: Exhaled Breath Collection, Other: Blood sampleExhaled breathe condensate will be collected using R-tube and ReCIVA device over 5-10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exhaled Breath CollectionExhaled 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 | Exhaled Breath Analysis |
| Blood sampleBlood samples collected simultaneously with routine standard of care blood draws. | Other | Exhaled Breath Analysis |
Primary outcome
Variability of Biomarkers
Time frame: At baseline and one month after completion of chemotherapy
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.
1 secondary outcome
Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT
Time frame: One month after completion of chemotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Farris, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exhaled Breath Collection and Blood sample in people with Pneumonitis and Nonsmall Cell Lung Cancer Stage III, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability of Biomarkers (time frame: At baseline and one month after completion of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.