Clinical trial NCT01252485: Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - The Biology and Outcome (BiO)-Project
Official title: Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - The Biology and Outcome (BiO)-Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia (AML)
MDS/AML
Keywords: AML
Registry study
Biology and Outcome
MDS/AML
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2010-12-03
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with newly diagnosed or relapsed/refractory AML in all AMLSG participating centers (80-90 centers in Germany and Austria)

Brief summary: 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)


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.

Primary outcomes:
measure: incidence of disease-related genetic markers
timeFrame: 4 weeks
measure: Event-free survival
timeFrame: 10 years
measure: Cumulative incidence of relapse
timeFrame: 10 years
measure: Cumulative incidence of death
timeFrame: 10 years
measure: Overall survival
timeFrame: 10 years
measure: Treatment decision (intensive, non-intensive, investigational)
timeFrame: 1 year
measure: quality of life
timeFrame: 2 years
measure: Geographical representation
timeFrame: 1 day
measure: Response to therapy
timeFrame: 1 year
measure: Relapse-free survival
timeFrame: 10 years
measure: Measurable residual disease (MRD)
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz GmbH
city: Linz
country: Austria
facility: Kepler Universitätsklinikum GmbH
city: Rankweil
country: Austria
facility: Landeskrankenhaus Feldkirch
city: Salzburg
country: Austria
facility: Universitätsklinikum der PMU Landeskrankenhaus Salzburg
city: Wien
country: Austria
facility: Hanuschkrankenhaus Wien
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Aurich
country: Germany
facility: Ubbo-Emmius-Klinik Aurich
city: Bad Saarow
country: Germany
facility: Helios Klinikum Bad Saarow
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban
city: Berlin
country: Germany
facility: Vivantes Netzwerk für Gesundheit GmbH Klinikum Neukölln
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin Campus Virchow Klinikum
city: Berlin
country: Germany
facility: Vivantes Klinikum Spandau
city: Bochum
country: Germany
facility: Augusta-Kranken-Anstalt
city: Bochum
country: Germany
facility: Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig
city: Bremen
country: Germany
facility: Klinikum Bremen-Mitte gGmbH
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt
city: Dortmund
country: Germany
facility: St. Johannes Hospital
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Düsseldorf
country: Germany
facility: Marien Hospital Düsseldorf GmbH
city: Essen
country: Germany
facility: Kliniken Essen-Süd Evang. Krankenhaus Essen-Werden gGmbH
city: Esslingen
country: Germany
facility: Klinikum Esslingen GmbH
city: Flensburg
country: Germany
facility: St. Franziskus Hospital
city: Frankfurt
country: Germany
facility: Städtische Kliniken Frankfurt am Main-Höchst
city: Freiburg
country: Germany
facility: Medizinische Universitätsklinik
city: Fulda
country: Germany
facility: MVZ Osthessen Medizinisches Versorgungszentrum
city: Gießen
country: Germany
facility: Klinik der Justus-Liebig-Universität
city: Goch
country: Germany
facility: Wilhelm-Anton-Hospital gGmbH
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Göppingen
country: Germany
facility: Alb Fils Kliniken GmbH
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Hamburg
country: Germany
facility: Asklepios Kliniken Hamburg GmbH St. Georg
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm
city: Hanau
country: Germany
facility: Klinikum Hanau gGmbH
city: Hannover
country: Germany
facility: Klinikum Hannover Siloah
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heilbronn
country: Germany
facility: SLK-Kliniken Heilbronn GmbH
city: Herne
country: Germany
facility: Marienhospital Herne Klinikum der Ruhr-Universität Bochum
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum Kaiserslautern
city: Karlsruhe
country: Germany
facility: Städtisches Klinikum Karlsruhe
city: Karlsruhe
country: Germany
facility: St. Vincentius-Kliniken Karlsruhe
city: Kiel
country: Germany
facility: Städtisches Krankenhaus Kiel GmbH
city: Krefeld
country: Germany
facility: Helios Klinikum Krefeld
city: Landshut
country: Germany
facility: Klinikum Landshut gGmbH
city: Lebach
country: Germany
facility: Caritas Krankenhaus Lebach
city: Lemgo
country: Germany
facility: Klinikum Lippe-Lemgo
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH
city: Lübeck
country: Germany
facility: Universitätslinikum Schleswig-Holstein, Lübeck
city: Lüdenscheid
country: Germany
facility: Klinikum Lüdenscheid
city: Magdeburg
country: Germany
facility: Univ-Klinikum der Otto-von-Guericke-Universität
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg gGmbH
city: Mainz
country: Germany
facility: Universitätsklinikum der Johannes Gutenberg-Universität Mainz
city: Meschede
country: Germany
facility: Klinikum Hochsauerland GmbH
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Mutlangen
country: Germany
facility: Klinikum Schwäbisch-Gmünd
city: Mühlheim
country: Germany
facility: Evangelisches Krankenhaus Mülheim an der Ruhr GmbH
city: München
country: Germany
facility: Klinikum Schwabing
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München
city: Neuss
country: Germany
facility: Städtische Kliniken Neuss Lukaskrankenhaus GmbH
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach
city: Offenburg
country: Germany
facility: Ortenau Klinikum, Offenburg-Gengenbach
city: Oldenburg
country: Germany
facility: Pius Hospital Oldenburg
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg gGmbH
city: Passau
country: Germany
facility: Klinikum Passau
city: Potsdam
country: Germany
facility: Ernst-von-Bergmann-Klinikum Potsdam gGmbH
city: Recklinghausen
country: Germany
facility: Klinikum Vest
city: Regensburg
country: Germany
facility: Universitätsklinikum
city: Saarbrücken
country: Germany
facility: Akademisches Lehrkrankenhaus des Saarlandes St. Theresia
city: Saarlouis
country: Germany
facility: Marienhaus Klinikum St. Elisaeth Saarlouis
city: Sande
country: Germany
facility: Nordwest-Krankenhaus Sanderbusch
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart Katharinenhospital
city: Stuttgart
country: Germany
facility: Diakonie-Klinikum Stuttgart
city: Stuttgart
country: Germany
facility: Vinzenz von Paul Kliniken gGmbH Marienhospital Stuttgart
city: Traunstein
country: Germany
facility: Klinikum Traunstein
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromäerinnen gGmbH
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier
city: Tübingen
country: Germany
facility: Medizinische Universitätsklinik Tübingen
city: Ulm
country: Germany
facility: University Hospital of Ulm
city: Ulm
country: Germany
facility: Universitätsklinik Ulm Labor für Zytogenetische und Molekulare Diagnostik
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
city: Wernigerode
country: Germany
facility: Harzklinikum Dorothea Christiane Erxleben
city: Wuppertal
country: Germany
facility: Helios Klinikum Wuppertal
Study officials:
affiliation: University Hospital of Ulm
name: Hartmut Döhner, Prof. Dr.
role: STUDY_CHAIR
References: