VOC in Breath Samples for the Diagnosis of IPA

NCT05982912 | Unknown

• 1 other identifier: RMB-22-0398
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Invasive Pulmonary Aspergillosis; Breath Samples; Volatile Organic Compounds

Outcome Measures

Primary Outcomes (1)

• Invasive Pulmonary Aspergillosis

  The diagnosis of Invasive Pulmonary Aspergillosis will be defined according to the updated EORTC criteria

  within 2 years from inrollment

Study Arms (1)

Patients that developed Invasive Pulmonary Aspergillosis

All patients sampled who later on developed IPA

Diagnostic Test: breath sampling

Interventions

breath sampling DIAGNOSTIC_TEST

We collect a breath sample of exhaled air and analyse the VOC profile in this sample

Patients that developed Invasive Pulmonary Aspergillosis

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients newly diagnosed with AML initiating treatment in the RMC hematology department will be approached.

You may qualify if:

• New diagnosis of acute myeloid leukemia AND/OR planned hematopoietic stem cells transplantation (HCT)
• Chest CT performed within 30 days from sampling
• years of age or older
• The ability to provide tidal breath samples totalling 10L directly into a Tedlar bag

You may not qualify if:

• Any condition impairing the patient's ability to provide informed consent

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Healthcare Campus

Haifa, 9619002, Israel

RECRUITING

MeSH Terms

Conditions

Invasive Pulmonary Aspergillosis

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Lung Diseases, Fungal; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Ivan GUR, MD

CONTACT

0542555655; ostyly@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: March 3, 2022
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting Dec 2025, indefinetely
• Access Criteria: upon resonable request at ostyly@gmail.com

Locations

IL (1)