Real-Time Breath Analysis in Acute Myeloid Leukaemia for a Rapid Characterisation of Biological Subtypes and to Predict Therapy Responses (EXHALE)
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Jeremy W Deuel, PD MD PhD
- Telefonnummer: +41 41 255 11 11
- E-mail: haematologie-onkologie@usz.ch
Undersøgelse Kontakt Backup
- Navn: Kevin D Hofer, MD
- Telefonnummer: +41 255 11 11
- E-mail: haematologie-onkologie@usz.ch
Studiesteder
-
-
Canton of Zurich
-
Zurich, Canton of Zurich, Schweiz, 8091
- University Hospital of Zurich
-
Kontakt:
- Jeremy W Deuel, PD MD PhD
- Telefonnummer: +41 41 255 11 11
- E-mail: haematologie-onkologie@usz.ch
-
Kontakt:
- Kevin D Hofer, MD
- Telefonnummer: +41 41 255 11 11
- E-mail: haematologie-onkologie@usz.ch
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
A breath metabolite signature representing AML disease burden
Tidsramme: 8 weeks
|
A breath metabolite signature representing AML disease burden, and might represent novel AML subtypes or describe cancer metabolic status.
|
8 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Jeremy W Deuel, PD MD PhD, University of Zurich
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- HumRes68544 (Registry Identifier: humanforschung-schweiz.ch)
- SNCTP000007074 (Registry Identifier: SNCTP)
- BASEC2026-00409 (Registry Identifier: swissethics / BASEC)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .