Clinical trial · Observational
Breath Analysis for the Detection of Invasive Fungal Infections
Real-time Breath Analysis for the Detection of Invasive Fungal Infections in Neutropenic High-risk Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Neutropenia | — | UNRESOLVED | — |
| Invasive Fungal Infections | — | UNRESOLVED | — |
| Invasive Pulmonary Aspergillosis | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Leukemia, Lymphoblastic | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Leukemia, Myeloid | Myeloid Leukemia | ALIAS | 0.90 |
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- No invasive fungal disease
- description
- Patients, that retrospectively do not have evidence of IFI
- interventionNames
- Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
- label
- Possible invasive fungal disease
- description
- 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.
- interventionNames
- Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
- label
- Probable invasive fungal disease
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available