Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis

Wake Forest University (WFU)

Status

Terminated

Conditions

Nonsmall Cell Lung Cancer Stage III

Pneumonitis

Treatments

Other: Blood sample

Other: Exhaled Breath Collection

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04040244

P30CA012197 (U.S. NIH Grant/Contract)

IRB00059924

NCI-2019-05682 (Other Identifier)

WFBCCC 98119 (Other Identifier)

Details and patient eligibility

About

This is a prospective pilot study investigating exhaled breath condensate analyses to quantify the variability over time of various biomarkers associated with symptomatic pneumonitis.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.