Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared Spectroscopy
- Conditions
- Lung Transplant Rejection
- Interventions
- Diagnostic Test: Breathe sample
- Registration Number
- NCT06309628
- Lead Sponsor
- Paragonix Technologies
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lung Transplant patients at risk for rejection Breathe sample Patients who have had a lung transplant and are getting a bronchoscopy to test for rejection will provide a breathe sample. Once their rejection results come back after their sample has been collected their breathe samples will be sorted into rejection and non-rejection groups for analysis. All patients will have the same experiences in the study.
- Primary Outcome Measures
Name Time Method Volatile Organic Compound profile three to twelve months post-transplant The VOCs in the breath of patients experiencing lung rejection post-transplant per bronchoscopy will be compared to lung transplant patients who are not experiencing rejection
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Duke University
🇺🇸Durham, North Carolina, United States