Real-Time Breath Analysis in Acute Myeloid Leukaemia for a Rapid Characterisation of Biological Subtypes and to Predict Therapy Responses (EXHALE)

September 16, 2026 updated by: Jeremy Deuel

Exhalomics for Phenotyping and Real-Time Stratification in Acute Myeloid Leukaemia (EXHALE)

Patients with acute myeloid leukaemia (AML) respond to treatment to differing degrees, owing to the biological diversity of the disease. The diagnostic tests currently available for identifying genetic alterations and selecting the best possible treatment usually take several days before a result is obtained. In our study, the investigators aim to determine whether breath analysis can detect metabolic products of the leukaemia that allow the disease to be classified rapidly.

Participants will undergo additional blood tests and a breath analysis during their routine appointments. This will take place only during the 1st and 2nd treatment cycles. They will also be asked to complete a questionnaire about their state of health. In addition, the study team will collect further information on their state of health (type of leukaemia, type of treatment, other medications, vital signs) from their medical records.

In total, participants will complete 4 such measurements before and during their treatment. The measurements will be coordinated with their outpatient appointments. No assessments will be carried out unless the participants are at the hospital in any case, and they will not have to attend the hospital more often because of their participation in this study.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

100 AML patients and 20 autologous-transplant controls

Description

Inclusion Criteria:

  • Diagnosis of an acute myeloid leukaemia and undergoing treatment
  • OR undergoing autoHSCT for lymphoid/myeloma disease in remission

Exclusion Criteria:

  • inability to perform brath analysis
  • anatomical barriers preventing use of the mouthpiece.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
AML
Patient with the Diagnosis (initial or relapsed/refractory) of AML
Negative Controls
Patients undergoing high-dose Chemotherapy with autologous stem cell support (autoHSCT) due to lymphoma or myeloma in remission

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A breath metabolite signature representing AML disease burden
Time Frame: 8 weeks
A breath metabolite signature representing AML disease burden, and might represent novel AML subtypes or describe cancer metabolic status.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jeremy Deuel

Collaborators

University Hospital, Zürich
ETH Zurich

Investigators

  • Principal Investigator: Jeremy W Deuel, PD MD PhD, University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 21, 2026

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

September 9, 2026

First Submitted That Met QC Criteria

September 16, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HumRes68544 (Registry Identifier: humanforschung-schweiz.ch)
  • SNCTP000007074 (Registry Identifier: SNCTP)
  • BASEC2026-00409 (Registry Identifier: swissethics / BASEC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Mass Spectrometry Raw Data of Study Participants will be made available on an appropriate platform.

IPD Sharing Time Frame

Beginning 3 months after publication with no end date.

IPD Sharing Access Criteria

unrestricted access

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe