Breath Analysis for the Detection of Invasive Fungal Infections

NCT06537726 | Recruiting

• 1 other identifier: SNCTP000005947
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  Feature in Mass Spectrometry

  through study completion, on average after 3 weeks

Secondary Outcomes (2)

• Specificity and sensitivity of this novel biomarker

  through study completion, on average after 3 weeks

• Anticipation of IFI

  through study completion, on average after 3 weeks

Study Arms (4)

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

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.

Also known as: Blood sampling (serologic biomarkers, PCR), Sputum analysis, Low-dose CT

No invasive fungal disease; Possible invasive fungal disease; Probable invasive fungal disease; Proven invasive fungal disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Diagnosis of acute leukemia
• Planned chemotherapy with a duration of hospitalisation of 2 weeks or longer

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, sputum

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neutropenia; Invasive Fungal Infections; Invasive Pulmonary Aspergillosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders; Mycoses; Bacterial Infections and Mycoses; Infections; Pulmonary Aspergillosis; Aspergillosis; Lung Diseases, Fungal; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jeremy Deuel, PD Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigaor

Study Record Dates

• First Submitted: July 27, 2024
• First Posted: August 5, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

CH (1)