The Identification of Volatile Organic Compunds Profiles Predictive of Invasive Pulmonary Aspergillosis in Breath Samples

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The diagnosis of invasive pulmonary aspergillosis (IPA) bears grave implications for the prognosis and treatment plan of the immunosuppressed patient. Thus far, such diagnosis in the immunosuppressed patient, such as patients with acute myeloid leukemia (AML), relied heavily on chest computed tomography (CT) and bronchoalveolar lavage (BAL), an invasive approach bearing many caveats. Volatile organic compounds (VOC) are compounds that could be detected in exhaled air, and have shown some potential in the non-invasive diagnosis of various conditions, including IPA. In this prospective longitudinal study we aim to compare the VOC profiles of patients diagnosed with AML (baseline) to the profile of the same patient diagnosed with IPA later on, and to the post recovery profile in the same patient. This approach should resolve many of the issues plaguing prior attempts at VOC based IPA diagnosis, mainly the lack of properly designed controls. Samples will be collected from consenting patients using Tedlar bags, and analyzed using thermal desorption gas chromatography mass spectrometry (TD-GC-MS). VOCs detected will be digitally analyzed to construct different classification models, with predictive performances compared to the clinical diagnosis using the accepted methods will be assessed by binary logistic regression.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 18
Healthy Volunteers: f
View:

• New diagnosis of acute myeloid leukemia AND/OR planned hematopoietic stem cells transplantation (HCT)

• Chest CT performed within 30 days from sampling

• 18 years of age or older

• The ability to provide tidal breath samples totalling 10L directly into a Tedlar bag

Locations
Other Locations
Israel
Rambam Healthcare Campus
RECRUITING
Haifa
Contact Information
Primary
Ivan GUR, MD
ostyly@gmail.com
0542555655
Time Frame
Start Date: 2022-03-03
Estimated Completion Date: 2025-12
Participants
Target number of participants: 200
Treatments
Patients that developed Invasive Pulmonary Aspergillosis
All patients sampled who later on developed IPA
Sponsors
Leads: Rambam Health Care Campus

This content was sourced from clinicaltrials.gov