Using breath samples to diagnose invasive pulmonary aspergillosis in leukemia patients
The Identification of Volatile Organic Compunds Profiles Predictive of Invasive Pulmonary Aspergillosis in Breath Samples
This study is testing if analyzing breath samples can help doctors diagnose invasive pulmonary aspergillosis in patients with leukemia without needing invasive procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 18 Years |
| Sex | All |
| Sponsor | Rambam Health Care Campus Academic / other |
| Locations | 1 site (Haifa) |
| Trial ID | NCT05982912 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the use of volatile organic compounds (VOCs) in breath samples for the non-invasive diagnosis of invasive pulmonary aspergillosis (IPA) in patients with acute myeloid leukemia (AML). By comparing the VOC profiles of patients diagnosed with AML at baseline, during IPA diagnosis, and post-recovery, the study seeks to address the challenges of current diagnostic methods that rely heavily on invasive procedures like bronchoalveolar lavage. The study will collect breath samples from consenting patients to establish a clearer understanding of VOC patterns associated with IPA. This approach is designed to improve diagnostic accuracy and patient outcomes in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have a new diagnosis of acute myeloid leukemia or are planned for hematopoietic stem cell transplantation.
Not a fit: Patients who are unable to provide informed consent or have conditions that impair their ability to do so will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a less invasive and more accurate method for diagnosing invasive pulmonary aspergillosis in immunosuppressed patients.
How similar studies have performed: While the use of VOCs for diagnosis is a novel approach, previous studies have shown potential in non-invasive diagnostics for various conditions, suggesting a promising avenue for this method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Any condition impairing the patient's ability to provide informed consent
Where this trial is running
Haifa
- Rambam Healthcare Campus — Haifa, Israel (Recruiting)
Study contacts
- Study coordinator: Ivan GUR, MD
- Email: ostyly@gmail.com
- Phone: 0542555655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.