Status:
TERMINATED
Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pneumonitis
Nonsmall Cell Lung Cancer Stage III
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 assoc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04040244
Start Date
December 9 2019
End Date
March 10 2022
Last Update
October 11 2023
Active Locations (1)
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1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157