We expect to find a lower sensitivity, which may be counterbalanced by an increase in specificity in PB, making it still relevant for prediction of relapse.
ID
Bron
Verkorte titel
Aandoening
Acute myeloid leukemia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome measure is the prognostic value of (LSC) MRD in PB compared to BM for relapse free survival (RFS) and overall survival (OS).
Achtergrond van het onderzoek
We aim to determine and compare MRD in BM and PB with our current qualified MRD test. The study takes place at the Amsterdam UMC location VUmc and AMC. We take two extra tubes (14 ml total) of heparin blood at the same day as the planned BM sample in AML patients. We will also examine the correlation between the two samples. Moreover, we will examine the influence of hemodilution by numbering the BM collection tubes. We expect to find a lower sensitivity, which may be counterbalanced by an increase in specificity in PB, making it still relevant for prediction of relapse.
Doel van het onderzoek
We expect to find a lower sensitivity, which may be counterbalanced by an increase in specificity in PB, making it still relevant for prediction of relapse.
Onderzoeksopzet
At least one
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patient with:
- a diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML), or
- acute leukemia’s of ambiguous lineage according to WHO 2008 or
- a diagnosis of refractory anemia with excess of blasts (MDS) and IPSS-R score > 4.5.
Treated according to HOVON clinical trials with intensive chemotherapy;
Age 18 yr or older;
A bone marrow aspiration has been scheduled;
WHO performance status 0, 1 or 2;
Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Pregnant or lactating females;
Unwilling or not capable to use effective means of birth control.
Opzet
Deelname
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Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9690 |
| Ander register | METC VUmc : METC2021.0021 |