Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - The Biology and Outcome (BiO)-Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia (AML), MDS/AML. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms Investigator's sites: 80-90 sites in Germany and Austria Estimated duration of observation of an individual patient: 10 years maximum Objectives * To register all patients with AML and related neoplasms, newly diagnosed or relapsed/refractory in all AMLSG participating centers (completeness) * To perform rapid analyses of disease-related genetic markers (incidences, treatment recommendations) * To assess patient and family history, as well as patient characteristics * To evaluate treatment response (CR, CRh, CRi) and outcome data (event-free survival \[EFS\], relapse-free survival \[RFS\], cumulative incidence of relapse \[CIR\], cumulative incidence of death \[CID\], overall survival \[OS\]) * To evaluate the impact of measurable residual disease (MRD) by different methods * To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers) * To store biosamples from all patients (e.g., bone marrow, blood, plasma, normal tissue; e.g., skin biopsy, finger nails, hairs, sputum, or urine)
Primary outcome measures
- incidence of disease-related genetic markers [Time frame: 4 weeks]
- Event-free survival [Time frame: 10 years]
- Cumulative incidence of relapse [Time frame: 10 years]
- Cumulative incidence of death [Time frame: 10 years]
- Overall survival [Time frame: 10 years]
- Treatment decision (intensive, non-intensive, investigational) [Time frame: 1 year]
- quality of life [Time frame: 2 years]
- Geographical representation [Time frame: 1 day]
- Response to therapy [Time frame: 1 year]
- Relapse-free survival [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- Patients with suspected diagnosis of acute myeloid leukemia and related neoplasms, newly diagnosed or relapsed/refractory, classified according to the International Consensus Classification
- Age ≥ 18 years. There is no upper age limit.
- Signed written informed consent
Exclusion criteria
- Severe neurological or psychiatric disorder interfering with ability to give an informed consent
- No consent for registration, storage and processing of the individual patient and disease characteristics and course as well as information of the family physician about study participation
- No consent for biobanking of patient's biological specimens and performance of analyses on stored material.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 86 centers
- Klinikum Aschaffenburg — Aschaffenburg
- Klinikum Augsburg — Augsburg
- Ubbo-Emmius-Klinik Aurich — Aurich
- Helios Klinikum Bad Saarow — Bad Saarow
- Vivantes Klinikum am Urban — Berlin
- Vivantes Netzwerk für Gesundheit GmbH Klinikum Neukölln — Berlin
- Charité Universitätsmedizin Berlin Campus Virchow Klinikum — Berlin
- Helios Klinikum Emil von Behring — Berlin
- … and 78 more centers
Austria · 8 centers
- Medizinische Universität Graz — Graz
- Medizinische Universität Innsbruck — Innsbruck
- Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H. — Linz
- Krankenhaus der Elisabethinen Linz GmbH — Linz
- Kepler Universitätsklinikum GmbH — Linz
- Landeskrankenhaus Feldkirch — Rankweil
- Universitätsklinikum der PMU Landeskrankenhaus Salzburg — Salzburg
- Hanuschkrankenhaus Wien — Vienna
Identifiers
NCT: NCT01252485 · AMLSG BiO