About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Unable to follow instructions for breath analysis
Anatomic abnormalities precluding the use of a mouthpiece for breath analysis
Trial population
Patients with acute leukemia that are undergoing chemotherapy at the Department of Medical Oncology and Haematology at the University Hospital Zurich
Trial design
Case-control
Prospective
Treatments tested in this trial
Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
Diagnostic testIdentify 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.
Treatment groups
Trial outcomes
Primary outcomes
Novel biomarker (m/z value) for IFI by SESI-HRMS
Feature in Mass Spectrometry
Secondary outcomes
Specificity and sensitivity of this novel biomarker
Description of Accuracy and Precision of this novel biomarker
Anticipation of IFI
Timepoint of first detection in relation to first clinical symptoms of IFI
Sponsors and contacts
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