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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No invasive fungal disease | Patients, that retrospectively do not have evidence of IFI |
| |
| Possible invasive fungal disease | 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. |
| |
| Probable invasive fungal disease | 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. |
| |
| Proven invasive fungal disease | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS) | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Novel biomarker (m/z value) for IFI by SESI-HRMS | Feature in Mass Spectrometry | through study completion, on average after 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity and sensitivity of this novel biomarker | Description of Accuracy and Precision of this novel biomarker | through study completion, on average after 3 weeks |
| Anticipation of IFI | Timepoint of first detection in relation to first clinical symptoms of IFI |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute leukemia that are undergoing chemotherapy at the Department of Medical Oncology and Haematology at the University Hospital Zurich
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Deuel, PD Dr. | Contact | +41 44 255 11 11 | jeremy.deuel@usz.ch | |
| Kevin Hofer, Dr. | Contact | +41 44 255 11 11 | kevin.hofer@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Jeremy Deuel, PD Dr. | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Zurich | Recruiting | Zurich | Canton of Zurich | 8091 | Switzerland |
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Blood, sputum
|
| through study completion, on average after 3 weeks |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D007951 | Leukemia, Myeloid |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D009503 | Neutropenia |
| D000072742 | Invasive Fungal Infections |
| D055744 | Invasive Pulmonary Aspergillosis |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D007960 | Leukocyte Disorders |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D055732 | Pulmonary Aspergillosis |
| D001228 | Aspergillosis |
| D008172 | Lung Diseases, Fungal |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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