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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Jeremy W Deuel, PD MD PhD
- Telefonnummer: +41 41 255 11 11
- E-post: haematologie-onkologie@usz.ch
Studer Kontakt Backup
- Navn: Kevin D Hofer, MD
- Telefonnummer: +41 255 11 11
- E-post: haematologie-onkologie@usz.ch
Studiesteder
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-
Canton of Zurich
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Zurich, Canton of Zurich, Sveits, 8091
- University Hospital of Zurich
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Ta kontakt med:
- Jeremy W Deuel, PD MD PhD
- Telefonnummer: +41 41 255 11 11
- E-post: haematologie-onkologie@usz.ch
-
Ta kontakt med:
- Kevin D Hofer, MD
- Telefonnummer: +41 41 255 11 11
- E-post: haematologie-onkologie@usz.ch
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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AML
Patient with the Diagnosis (initial or relapsed/refractory) of AML
|
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Negative Controls
Patients undergoing high-dose Chemotherapy with autologous stem cell support (autoHSCT) due to lymphoma or myeloma in remission
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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A breath metabolite signature representing AML disease burden
Tidsramme: 8 weeks
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A breath metabolite signature representing AML disease burden, and might represent novel AML subtypes or describe cancer metabolic status.
|
8 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Jeremy W Deuel, PD MD PhD, University of Zurich
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- HumRes68544 (Registeridentifikator: humanforschung-schweiz.ch)
- SNCTP000007074 (Registeridentifikator: SNCTP)
- BASEC2026-00409 (Registeridentifikator: swissethics / BASEC)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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