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Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis

Primary Purpose

Pneumonitis, Nonsmall Cell Lung Cancer Stage III

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exhaled Breath Collection
Blood sample
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pneumonitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wake Forest Baptist Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exhaled Breath Analysis

Arm Description

Exhaled breathe condensate will be collected using R-tube and ReCIVA device over 5-10 minutes.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 29, 2019
Last Updated
September 18, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04040244
Brief Title
Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
March 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonitis, Nonsmall Cell Lung Cancer Stage III

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exhaled Breath Analysis
Arm Type
Experimental
Arm Description
Exhaled breathe condensate will be collected using R-tube and ReCIVA device over 5-10 minutes.
Intervention Type
Other
Intervention Name(s)
Exhaled Breath Collection
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
Blood samples collected simultaneously with routine standard of care blood draws.
Primary Outcome Measure Information:
Title
Variability of Biomarkers
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.
Time Frame
At baseline and one month after completion of chemotherapy
Secondary Outcome Measure Information:
Title
Differences in Concentrations of Biomarkers in Exhaled Breath Condensate From Baseline to 1 Month Post CRT
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Farris, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis

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