Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - the Biology and Outcome (BiO)-Project

Last updated: March 25, 2025
Sponsor: University of Ulm
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Leukemia (Pediatric)

Myelodysplastic Syndromes (Mds)

Treatment

N/A

Clinical Study ID

NCT01252485
AMLSG BiO
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients with suspected diagnosis of acute myeloid leukemia and related neoplasms,newly diagnosed or relapsed/refractory, classified according to the InternationalConsensus Classification

  • Age ≥ 18 years. There is no upper age limit.

  • Signed written informed consent

Exclusion

Exclusion Criteria:

  • Severe neurological or psychiatric disorder interfering with ability to give aninformed consent

  • No consent for registration, storage and processing of the individual patient anddisease characteristics and course as well as information of the family physicianabout study participation

  • No consent for biobanking of patient's biological specimens and performance ofanalyses on stored material.

Study Design

Total Participants: 50000
Study Start date:
July 06, 2010
Estimated Completion Date:
December 31, 2044

Connect with a study center

  • Landeskrankenhaus Feldkirch

    Feldkirch, 6807
    Austria

    Site Not Available

  • Medizinische Universität Graz

    Graz, 8036
    Austria

    Active - Recruiting

  • Medizinische Universität Innsbruck

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Kepler Universitätsklinikum GmbH

    Linz,
    Austria

    Active - Recruiting

  • Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.

    Linz, 4010
    Austria

    Suspended

  • Krankenhaus der Elisabethinen Linz GmbH

    Linz, 4020
    Austria

    Active - Recruiting

  • Landeskrankenhaus Feldkirch

    Rankweil, 6807
    Austria

    Active - Recruiting

  • Universitätsklinikum der PMU Landeskrankenhaus Salzburg

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Hanuschkrankenhaus Wien

    Wien, 1140
    Austria

    Active - Recruiting

  • Klinikum Aschaffenburg

    Aschaffenburg, 63739
    Germany

    Active - Recruiting

  • Klinikum Augsburg

    Augsburg, 86156
    Germany

    Suspended

  • Ubbo-Emmius-Klinik Aurich

    Aurich, 26603
    Germany

    Suspended

  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526
    Germany

    Active - Recruiting

  • Charité Universitätsmedizin Berlin Campus Virchow Klinikum

    Berlin, 13353
    Germany

    Active - Recruiting

  • Vivantes Klinikum Spandau

    Berlin,
    Germany

    Active - Recruiting

  • Vivantes Klinikum am Urban

    Berlin, 10967
    Germany

    Active - Recruiting

  • Vivantes Netzwerk für Gesundheit GmbH Klinikum Neukölln

    Berlin, 12351
    Germany

    Active - Recruiting

  • Augusta-Kranken-Anstalt

    Bochum, 44791
    Germany

    Active - Recruiting

  • Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum

    Bochum, 44892
    Germany

    Active - Recruiting

  • Universitätsklinikum Bonn

    Bonn, 53105
    Germany

    Active - Recruiting

  • Städtisches Klinikum Braunschweig

    Braunschweig, 38114
    Germany

    Active - Recruiting

  • Klinikum Bremen-Mitte gGmbH

    Bremen, 28177
    Germany

    Active - Recruiting

  • Klinikum Darmstadt

    Darmstadt, 64283
    Germany

    Active - Recruiting

  • St. Johannes Hospital

    Dortmund, 44137
    Germany

    Active - Recruiting

  • Marien Hospital Düsseldorf GmbH

    Düsseldorf,
    Germany

    Active - Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225
    Germany

    Active - Recruiting

  • Kliniken Essen-Süd Evang. Krankenhaus Essen-Werden gGmbH

    Essen, 45239
    Germany

    Active - Recruiting

  • Klinikum Esslingen GmbH

    Esslingen, 73730
    Germany

    Active - Recruiting

  • St. Franziskus Hospital

    Flensburg, 24939
    Germany

    Active - Recruiting

  • Städtische Kliniken Frankfurt am Main-Höchst

    Frankfurt, 65929
    Germany

    Active - Recruiting

  • Medizinische Universitätsklinik

    Freiburg, 79106
    Germany

    Active - Recruiting

  • MVZ Osthessen Medizinisches Versorgungszentrum

    Fulda, 36043
    Germany

    Suspended

  • Klinik der Justus-Liebig-Universität

    Gießen, 35385
    Germany

    Active - Recruiting

  • Wilhelm-Anton-Hospital gGmbH

    Goch, 47574
    Germany

    Active - Recruiting

  • Universitätsmedizin Greifswald

    Greifswald,
    Germany

    Active - Recruiting

  • Alb Fils Kliniken GmbH

    Göppingen, 73035
    Germany

    Active - Recruiting

  • Universitätsmedizin Göttingen

    Göttingen, 37075
    Germany

    Active - Recruiting

  • Asklepios Klinik Altona

    Hamburg, 22763
    Germany

    Active - Recruiting

  • Asklepios Kliniken Hamburg GmbH St. Georg

    Hamburg,
    Germany

    Active - Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Evangelisches Krankenhaus Hamm

    Hamm, 59063
    Germany

    Active - Recruiting

  • Klinikum Hanau gGmbH

    Hanau, 63450
    Germany

    Active - Recruiting

  • Klinikum Hannover Siloah

    Hannover, 30449
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Active - Recruiting

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078
    Germany

    Active - Recruiting

  • Marienhospital Herne Klinikum der Ruhr-Universität Bochum

    Herne, 44625
    Germany

    Active - Recruiting

  • Universitätsklinikum des Saarlandes

    Homburg/Saar, 66424
    Germany

    Active - Recruiting

  • Westpfalz-Klinikum Kaiserslautern

    Kaiserslautern, 67655
    Germany

    Active - Recruiting

  • St. Vincentius-Kliniken Karlsruhe

    Karlsruhe, 76137
    Germany

    Active - Recruiting

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133
    Germany

    Active - Recruiting

  • Städtisches Krankenhaus Kiel GmbH

    Kiel, 24116
    Germany

    Suspended

  • Helios Klinikum Krefeld

    Krefeld,
    Germany

    Active - Recruiting

  • Klinikum Landshut gGmbH

    Landshut, 84034
    Germany

    Active - Recruiting

  • Caritas Krankenhaus Lebach

    Lebach, 66822
    Germany

    Active - Recruiting

  • Klinikum Lippe-Lemgo

    Lemgo, 32657
    Germany

    Active - Recruiting

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, 67063
    Germany

    Active - Recruiting

  • Universitätslinikum Schleswig-Holstein, Lübeck

    Lübeck, 23538
    Germany

    Active - Recruiting

  • Klinikum Lüdenscheid

    Lüdenscheid, 58515
    Germany

    Active - Recruiting

  • Klinikum Magdeburg gGmbH

    Magdeburg, 39130
    Germany

    Active - Recruiting

  • Univ-Klinikum der Otto-von-Guericke-Universität

    Magdeburg, 39120
    Germany

    Active - Recruiting

  • Universitätsklinikum der Johannes Gutenberg-Universität Mainz

    Mainz, 55131
    Germany

    Active - Recruiting

  • Klinikum Hochsauerland GmbH

    Meschede, 59872
    Germany

    Active - Recruiting

  • Johannes Wesling Klinikum Minden

    Minden, 32429
    Germany

    Active - Recruiting

  • Klinikum Schwäbisch-Gmünd

    Mutlangen, 73557
    Germany

    Active - Recruiting

  • Evangelisches Krankenhaus Mülheim an der Ruhr GmbH

    Mühlheim, 45466
    Germany

    Active - Recruiting

  • Klinikum Schwabing

    München, 80804
    Germany

    Suspended

  • Klinikum rechts der Isar der TU München

    München, 81675
    Germany

    Active - Recruiting

  • Städtische Kliniken Neuss Lukaskrankenhaus GmbH

    Neuss, 41464
    Germany

    Suspended

  • Sana Klinikum Offenbach

    Offenbach, 63069
    Germany

    Active - Recruiting

  • Ortenau Klinikum, Offenburg-Gengenbach

    Offenburg, 77654
    Germany

    Active - Recruiting

  • Klinikum Oldenburg gGmbH

    Oldenburg, 26133
    Germany

    Active - Recruiting

  • Pius Hospital Oldenburg

    Oldenburg, 26121
    Germany

    Active - Recruiting

  • Klinikum Passau

    Passau, 94032
    Germany

    Active - Recruiting

  • Ernst-von-Bergmann-Klinikum Potsdam gGmbH

    Potsdam, 14467
    Germany

    Active - Recruiting

  • Klinikum Vest

    Recklinghausen, 45657
    Germany

    Active - Recruiting

  • Universitätsklinikum

    Regensburg, 93053
    Germany

    Active - Recruiting

  • Akademisches Lehrkrankenhaus des Saarlandes St. Theresia

    Saarbrücken, 66113
    Germany

    Active - Recruiting

  • Marienhaus Klinikum St. Elisaeth Saarlouis

    Saarlouis,
    Germany

    Active - Recruiting

  • Nordwest-Krankenhaus Sanderbusch

    Sande,
    Germany

    Active - Recruiting

  • Diakonie-Klinikum Stuttgart

    Stuttgart, 70176
    Germany

    Active - Recruiting

  • Klinikum Stuttgart Katharinenhospital

    Stuttgart, 70174
    Germany

    Active - Recruiting

  • Vinzenz von Paul Kliniken gGmbH Marienhospital Stuttgart

    Stuttgart, 70199
    Germany

    Active - Recruiting

  • Klinikum Traunstein

    Traunstein, 83278
    Germany

    Active - Recruiting

  • Klinikum Mutterhaus der Borromäerinnen gGmbH

    Trier, 54290
    Germany

    Active - Recruiting

  • Krankenhaus der Barmherzigen Brüder Trier

    Trier, 54292
    Germany

    Active - Recruiting

  • Medizinische Universitätsklinik Tübingen

    Tübingen, 72076
    Germany

    Active - Recruiting

  • University Hospital of Ulm

    Ulm, 89081
    Germany

    Active - Recruiting

  • Universitätsklinik Ulm Labor für Zytogenetische und Molekulare Diagnostik

    Ulm, 89081
    Germany

    Active - Recruiting

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

    Villingen-Schwenningen, 78052
    Germany

    Active - Recruiting

  • Harzklinikum Dorothea Christiane Erxleben

    Wernigerode, 38855
    Germany

    Active - Recruiting

  • Helios Klinikum Wuppertal

    Wuppertal, 42283
    Germany

    Active - Recruiting

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