Chemotherapy-induced Neutropenia, Invasive Fungal Infections, Invasive Pulmonary Aspergillosis, Leukemia, Leukemia, Lymphoblastic, Leukemia, Myeloid, Neutropenia
Conditions
Brief summary
Patients with leukemia and concomitant neutropenia are at high risk of developing invasive fungal infections (IFI) that are associated with high morbidity and mortality. As these patients typically have severe thrombocytopenia, direct diagnostic sampling with invasive procedures is often not possible due to the high peri-interventional risk. Therefore, the presumptive diagnosis of IFI is primarily based on compatible lung findings on computed tomography and serologic detection of fungal cell wall components, which, however, have limited sensitivity and specificity. With the present study, the investigators aim to determine a set of specific volatile biomarkers in leukemia patients with proven or probable IFI using secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS).
Interventions
DIAGNOSTIC_TESTSecondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
Identify volatile biomarkers of IFI by analyzing the breath metabolome of patients with proven or probable IFI according to the criteria outlined by EORTC/MSG and controls.
Sponsors
University of Zurich
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of acute leukemia * Planned chemotherapy with a duration of hospitalisation of 2 weeks or longer * Neutropenia (\<500/µl) present at inclusion or planned chemotherapy with expected neutropenia (\<500/µl) for more than 7 days
Exclusion criteria
* Unable to follow instructions for breath analysis * Anatomic abnormalities precluding the use of a mouthpiece for breath analysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Novel biomarker (m/z value) for IFI by SESI-HRMS | through study completion, on average after 3 weeks | Feature in Mass Spectrometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity and sensitivity of this novel biomarker | through study completion, on average after 3 weeks | Description of Accuracy and Precision of this novel biomarker |
| Anticipation of IFI | through study completion, on average after 3 weeks | Timepoint of first detection in relation to first clinical symptoms of IFI |
Countries
Switzerland
Contacts
Primary ContactJeremy Deuel, PD Dr.
Backup ContactKevin Hofer, Dr.
Outcome results
None listed