An observational study in Leukemia, Leukemia, Myeloid and Leukemia, Lymphoblastic, sponsored by University of Zurich. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by University of Zurich · Observational
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).
Patients with acute leukemia that are undergoing chemotherapy at the Department of Medical Oncology and Haematology at the University Hospital Zurich
Exclusion Criteria:
Patients, that retrospectively do not have evidence of IFI
Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
Patients, that retrospectively have a possible IFI (according to EORTC guidelines). There is suspicion of IFI by clinical or radiological features, but no microbiological evidence of IFI.
Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
Patients, that retrospectively have a probable IFI (according to EORTC guidelines). There is suspicion of IFI by clinical or radiological features, and indirect microbiological evidence of IFI.
Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
Patients, that retrospectively have a proven IFI (according to EORTC guidelines). There is histological (angioinvasive growth of a fungus) or definitive microbiological evidence of IFI, e.g. evidence of a fungus from a sterile tissue.
Diagnostic Test: Secondary 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.
Also known as: Blood sampling (serologic biomarkers, PCR), Sputum analysis, Low-dose CT
Novel biomarker (m/z value) for IFI by SESI-HRMS
Feature in Mass Spectrometry
Time frame: through study completion, on average after 3 weeks
Specificity and sensitivity of this novel biomarker
Description of Accuracy and Precision of this novel biomarker
Time frame: through study completion, on average after 3 weeks
Anticipation of IFI
Timepoint of first detection in relation to first clinical symptoms of IFI
Time frame: through study completion, on average after 3 weeks
Plan to share: Undecided
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University of Zurich