Clinical trial · Interventional
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
NCT04040244CI-TRIAL-00070410terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
This is a prospective pilot study investigating exhaled breath condensate analyses to quantify the variability over time of various biomarkers associated with symptomatic pneumonitis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nonsmall Cell Lung Cancer Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Pneumonitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Other | — | UNRESOLVED |
| Exhaled Breath Collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exhaled Breath Analysis
- description
- Exhaled breathe condensate will be collected using R-tube and ReCIVA device over 5-10 minutes.
- interventionNames
- Other: Exhaled Breath Collection
- Other: Blood sample
Primary outcomes (1)
- measure
- Variability of Biomarkers
- timeFrame
- At baseline and one month after completion of chemotherapy
- description
- 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.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.