LeukemiaREDEFINENCT06537726
Breath Analysis for the Detection of Invasive Fungal Infections
An observational study of Leukemia and Leukemia, Myeloid, run by University of Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Leukemia, Myeloid, Leukemia, Lymphoblastic
- What is being tested?
- Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
- How many people
- 130 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Aug 2024to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute leukemia that are undergoing chemotherapy at the Department of Medical Oncology and Haematology at the University Hospital Zurich
Who may be able to join
- 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
Who cannot join
- Unable to follow instructions for breath analysis
- Anatomic abnormalities precluding the use of a mouthpiece for breath analysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Zurich
Zurich, Canton of Zurich, 8091
Jeremy Deuel, PD Dr. Dr., +41442551111, jeremy.deuel@usz.ch
Kevin Hofer, Dr., +41442551111, kevin.hofer@usz.ch
About this study
Official title: Real-time Breath Analysis for the Detection of Invasive Fungal Infections in Neutropenic High-risk Patients
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
- Leukemia, Leukemia, Myeloid, Leukemia, Lymphoblastic, Neutropenia, Chemotherapy-induced Neutropenia, Invasive Fungal Infections
- Being tested
- Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neutropenia, Invasive Fungal Infections, Invasive Pulmonary Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)Diagnostic test
Also called Blood sampling (serologic biomarkers, PCR), Sputum analysis, Low-dose CT
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.
| Study group | Role | What they receive |
|---|---|---|
| No invasive fungal disease | Patients, that retrospectively do not have evidence of IFI Receives: Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS) | |
| 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. Receives: Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS) | |
| 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. Receives: Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS) | |
| 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. Receives: Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Novel biomarker (m/z value) for IFI by SESI-HRMS
Feature in Mass Spectrometry
Measured: through study completion, on average after 3 weeks
Secondary outcomes (2)
Specificity and sensitivity of this novel biomarker
Description of Accuracy and Precision of this novel biomarker
Measured: through study completion, on average after 3 weeks
Anticipation of IFI
Timepoint of first detection in relation to first clinical symptoms of IFI
Measured: through study completion, on average after 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start19 Aug 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Deuel, University of Zurich
- Investigators
- Jeremy Deuel, PD Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537726
- Sponsor's protocol ID
- SNCTP000005947
- Acronym
- REDEFINE
- Status last verified
- Apr 2025
- First submitted
- 27 Jul 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Breath Analysis for the Detection of Invasive Fungal Infections in Neutropenic High-risk Patients
- ClinicalTrials.gov ID
- NCT06537726
- Acronym / sponsor ID
- REDEFINE / SNCTP000005947
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Lymphoblastic, Neutropenia, Chemotherapy-induced Neutropenia, Invasive Fungal Infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No invasive fungal disease | – | Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)Patients, that retrospectively do not have evidence of IFI |
| Possible invasive fungal disease | – | 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. |
| Probable invasive fungal disease | – | 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. |
| Proven invasive fungal disease | – | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute leukemia that are undergoing chemotherapy at the Department of Medical Oncology and Haematology at the University Hospital Zurich
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to follow instructions for breath analysis
- Anatomic abnormalities precluding the use of a mouthpiece for breath analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)Also: Blood sampling (serologic biomarkers, PCR), Sputum analysis, Low-dose CTIdentify 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. | Diagnostic test | No invasive fungal disease, Possible invasive fungal disease, Probable invasive fungal disease, Proven invasive fungal disease |
Primary outcome
Novel biomarker (m/z value) for IFI by SESI-HRMS
Time frame: through study completion, on average after 3 weeks
Feature in Mass Spectrometry
2 secondary outcomes
Specificity and sensitivity of this novel biomarker
Time frame: through study completion, on average after 3 weeks
Anticipation of IFI
Time frame: through study completion, on average after 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeremy Deuel, PD Dr. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Leukemia, Myeloid, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeremy Deuel, PD Dr. (+41 44 255 11 11, jeremy.deuel@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Novel biomarker (m/z value) for IFI by SESI-HRMS (time frame: through study completion, on average after 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.