Exhaled Breath Analysis to Predict Risk of Symptomatic Pneumonitis

NCT04040244 | Terminated Results DMC

• 4 other identifiers: IRB00059924WFBCCC 98119NCI-2019-05682P30CA012197
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonitis; Nonsmall Cell Lung Cancer Stage III

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  One month after completion of chemotherapy

Study Arms (1)

Exhaled Breath Analysis

EXPERIMENTAL

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

Other: Exhaled Breath Collection; Other: Blood sample

Interventions

Exhaled Breath Collection OTHER

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.

Exhaled Breath Analysis

Blood sample OTHER

Blood samples collected simultaneously with routine standard of care blood draws.

Exhaled Breath Analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pneumonia; Carcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Study Coordinator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

jkettler@wakehealth.edu

336-716-4760

Study Officials

• Michael Farris, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: December 9, 2019
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: October 11, 2023
• Results First Posted: October 11, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)