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

NCT07826897 | Not Yet Recruiting

• 3 other identifiers: HumRes68544SNCTP000007074BASEC2026-00409
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

AML

Keywords

Exhalomics; Breath Analysis; AML; Biomarker

Outcome Measures

Primary Outcomes (1)

• A breath metabolite signature representing AML disease burden

  A breath metabolite signature representing AML disease burden, and might represent novel AML subtypes or describe cancer metabolic status.

  8 weeks

Study Arms (2)

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

Eligibility Criteria

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

Study Population

100 AML patients and 20 autologous-transplant controls

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jeremy Deuel: lead
• University Hospital, Zürich: collaborator
• ETH Zurich: collaborator

Study Sites (1)

University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, Cells

Study Officials

• Jeremy W Deuel, PD MD PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy W Deuel, PD MD PhD

CONTACT

+41 41 255 11 11; haematologie-onkologie@usz.ch

Kevin D Hofer, MD

CONTACT

+41 255 11 11; haematologie-onkologie@usz.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med. Dr. sc. nat.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 17, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Beginning 3 months after publication with no end date.
• Access Criteria: unrestricted access

Locations

CH (1)