Clinical trial NCT06309628: Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared Spectroscopy
Official title: Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Transplant Rejection
Lead sponsor: Paragonix Technologies
Sponsor class: INDUSTRY
Collaborators: name: Breathe BioMedical Inc
First posted: 2024-03-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of adult patients who are receiving a bronchoscopy at least 90 days after a lung transplant.

Brief summary: This study will sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant by using infrared spectroscopy.

Detailed description: The aim of this study is to sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant. By using infrared spectroscopy, the breath sample analysis will help investigators describe and identify patterns of VOCs that are over- or under-represented in patients with post-lung transplant rejection when compared to the breath profiles of those without rejection. It is hypothesized that the profile of volatile chemicals in the breath of patients in the early stages of rejection will differ significantly from those individuals without rejection.

Primary objective

• To analyze the breath-born VOCs in breath profiles of lung transplant patients with rejection in comparison to lung transplant patients without rejection using infrared spectroscopy to determine the presence of lung rejection and to develop mathematical/statistical models of infrared absorption spectrum for identification of rejection.

Secondary objective

* To determine the best method to classify health status based on VOC data of breath samples
* To validate early test results on an additional infrared spectroscopic analyzer in post-lung transplant patients

The study is an unblinded, prospective case-control study. The study cohorts will include: 1) patients with confirmed post-lung transplant rejection via biopsy, and 2) control patients who have undergone lung transplant but are free from rejection as confirmed via biopsy. Breath samples collected from participants will be analyzed to characterize and further identify differences in infrared absorption profiles from each cohort using infrared spectroscopy. The data will be used to validate a previously developed machine learning algorithm.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Patient is able to give informed consent
* Lung transplant patient who had both lungs transplanted
* Patient is at least 90 days after their lung transplant
* Patient is able to provide a breath sample

Exclusion Criteria:

* Patient is less than 18 years old
* Patient received multiple organ transplants
* Patient had an organ transplant prior to their lung transplant
* Patients who received a single lung transplant
* Patient less than 90 days or more than 1 year from their lung transplant
* If patient has smoked 4 hours or less before breath sample or consumed alcohol (including mouthwash) 8 hours or less before breath sample

Primary outcomes:
measure: Volatile Organic Compound profile
timeFrame: three to twelve months post-transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Matthew Hartwig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Matthew Pipeling
role: PRINCIPAL_INVESTIGATOR
References: