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RecruitingNCT06537726REDEFINEUpdated Apr 10, 2025

Breath Analysis for the Detection of Invasive Fungal Infections

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

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
130
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 67 studies in Leukemia with a site in Switzerland — 9 open to participants now, 12 under way, 2 of them phase 3. Leukemia · Switzerland.

Started
2024
with 3 others
Observational
7 of 67
3 open now
Primary completion
2027-10
later than 7 of 11 live
Registered
65th of 67
by date
Lead sponsor
2 of 67
University of Zurich

Among the 67 studies in Leukemia with a site in Switzerland, this one is one of 4 that started in 2024, is one of 7 observational ones, reaches primary completion later than 7 of the 11 other live ones, and was the 65th registered.

Leukemia

2,381 studies on the registry are indexed under Leukemia; 253 are open to participants now.

This study's planned enrollment of 130 is close to the median of 142 across 332 observational studies indexed under Leukemia.

Browse Leukemia studies →

Open to participants now

9 of the 67 studies in Leukemia with a site in Switzerland are open now, in 12 countries. Each count lists the studies.

All 9 open studies →

Who these studies take

Of the 208 Leukemia studies recruiting now, 112 (54%) set no upper age limit and 74 (36%) stop at 75 or younger; 86 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 67 studies in Leukemia with a site in Switzerland, or all of them as a file.
02

Study 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 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).

03

Conditions studied

  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Lymphoblastic
  • Neutropenia
  • Chemotherapy-induced Neutropenia
  • Invasive Fungal Infections
  • Invasive Pulmonary Aspergillosis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with acute leukemia that are undergoing chemotherapy at the Department of Medical Oncology and Haematology at the University Hospital Zurich

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Unable to follow instructions for breath analysis
  • Anatomic abnormalities precluding the use of a mouthpiece for breath analysis
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
130 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • No invasive fungal disease

    Patients, that retrospectively do not have evidence of IFI

    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.

    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.

    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.

    Diagnostic Test: Secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS)

Interventions

  • Diagnostic testSecondary 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

06

What researchers measure

Primary outcomes

  1. Novel biomarker (m/z value) for IFI by SESI-HRMS

    Feature in Mass Spectrometry

    Time frame: through study completion, on average after 3 weeks

Secondary outcomes

  1. 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

  2. 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

07

Study locations

1 of 1 sites recruiting
  • University Hospital of Zurich
    Zürich, 8091, Switzerland
    Recruiting
    • Jeremy Deuel, PD Dr. Dr. · Contactjeremy.deuel@usz.ch · +41442551111
    • Kevin Hofer, Dr. · Contactkevin.hofer@usz.ch · +41442551111
    • Jeremy Deuel, PD Dr. · Principal investigator
    • Kevin Hofer, Dr. · Sub investigator
    • Noriane Sievi · Sub investigator
    • Egli Adrian, Prof. Dr. · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Oct 2027, 38 months after the start.

Of 96 non-industry observational studies under Leukemia, half reached primary completion within 119 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 269. This study's planned 38 months is below that.

Counting every sponsor, half of 110 studies reached it within 119 months; a quarter within 40 and three quarters within 269.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2024
First posted
Aug 5, 2024
StartActual
Aug 19, 2024
Primary completionEst.
Oct 31, 2027
CompletionEst.
Oct 31, 2027
Last update
Apr 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06537726
Responsible party
Jeremy Deuel (Principal Investigaor, University of Zurich) — Principal investigator
First posted
Aug 5, 2024
Start date
Aug 19, 2024
Primary completion
Oct 31, 2027 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Apr 10, 2025

Study contacts

Jeremy Deuel, PD Dr.
Contact
jeremy.deuel@usz.ch
+41 44 255 11 11
Kevin Hofer, Dr.
Contact
kevin.hofer@usz.ch
+41 44 255 11 11
Jeremy Deuel, PD Dr.
principal investigator · University of Zurich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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