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Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Higher Risk Myelodysplastic Syndrome - The Biology and Outcome (BiO)-Project (AMLSG BiO)

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ClinicalTrials.gov Identifier: NCT01252485
Recruitment Status : Recruiting
First Posted : December 3, 2010
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Hartmut Doehner, University of Ulm

Brief Summary:

This is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms

Investigator's sites: 60-70 sites in Germany and Austria

Estimated duration of observation of an individual patient:

10 years maximum

Objectives

  • To register all patients with acute myeloid leukemia and related precursor neoplasms, acute leukemia of unambiguous lineage, with higher risk myelodysplastic syndromes (MDS with excess blasts 2), and with myeloid neoplasms with germline predisposition, newly diagnosed or relapsed/refractory in all participating centers (completeness)
  • To perform timely analyses of disease-related genetic markers (incidences, treatment recommendations)
  • To assess patient and family history, clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
  • 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, buccal swap, finger nails, hairs, or sputum)
  • To assess quality of life

Condition or disease
Acute Myeloid Leukemia (AML) Higher Risk Myelodysplastic Syndromes (MDS With Excess Blasts 2)

Study Type : Observational
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Higher Risk Myelodysplastic Syndrome - The Biology and Outcome (BiO)-Project
Study Start Date : July 2010





Primary Outcome Measures :
  1. incidence of disease-related genetic markers [ Time Frame: 4 weeks ]
    To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations)

  2. Event-free survival [ Time Frame: 10 years ]
    To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])

  3. Cumulative incidence of relapse [ Time Frame: 10 years ]
    To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])

  4. Cumulative incidence of death [ Time Frame: 10 years ]
    To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])

  5. Overall survival [ Time Frame: 10 years ]
    To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])

  6. Treatment decision (intensive, non-intensive, investigational) [ Time Frame: 1 year ]
    To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations)

  7. quality of life [ Time Frame: 5 years ]
    Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, socioeconomics, and demographics according to Messerer D et al (2008) initially, in first CR, one year, 3 and 5 years after initial diagnosis.

  8. Geographical representation [ Time Frame: 1 day ]
    Geographical representation of patients through collection of patients zip codes



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with newly diagnosed or relapsed/refractory AML in all AMLSG participating centers (60-70 centers in Germany and Austria)
Criteria

Inclusion Criteria:

  • Patients with suspected diagnosis of AML and related precursor neoplasms, acute leukemias of ambiguous lineages, higher risk MDS (MDS with excess blasts 2 [MDS-EB2]), and myeloid neoplasm with germline predisposition, newly diagnosed or relapsed/refractory, classified according to the World Health Organization (WHO) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252485


Contacts
Contact: Hartmut Döhner, Prof. Dr. 49-731-500-45501 hartmut.doehner@uniklinik-ulm.de

  Hide Study Locations
Locations
Austria
Landeskrankenhaus Feldkirch Recruiting
Feldkirch, Austria, 6807
Contact: Alois Lang, PD Dr.         
Medizinische Universität Graz Recruiting
Graz, Austria, 8036
Contact: Heinz Sill, Prof. Dr.         
Medizinische Universität Innsbruck Recruiting
Innsbruck, Austria, 6020
Contact: David Nachbaur, Prof. Dr.         
Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H. Recruiting
Linz, Austria, 4010
Contact: Andreas Petzer, Prof. Dr.         
Krankenhaus der Elisabethinen Linz GmbH Recruiting
Linz, Austria, 4020
Contact: Michael Girschikofsky, Dr.         
Universitätsklinikum der PMU Landeskrankenhaus Salzburg Recruiting
Salzburg, Austria, 5020
Contact: Richard Greil, Prof. Dr.         
Hanuschkrankenhaus Wien Recruiting
Wien, Austria, 1140
Contact: Elisabeth Koller, Dr.         
Germany
Klinikum Aschaffenburg Recruiting
Aschaffenburg, Germany, 63739
Contact: W. Fischbach, Prof. Dr. med.         
Klinikum Augsburg Recruiting
Augsburg, Germany, 86156
Contact: Rank, PD Dr.         
Ubbo-Emmius-Klinik Aurich Recruiting
Aurich, Germany, 26603
Contact: Dieter Reichert, Dr.         
Helios Klinikum Bad Saarow Recruiting
Bad Saarow, Germany, 15526
Contact: Daniel Schöndube, Dr.med.         
Vivantes Klinikum am Urban Recruiting
Berlin, Germany, 10967
Contact: Annette Dieing, Dr.         
Vivantes Netzwerk für Gesundheit GmbH Klinikum Neukölln Recruiting
Berlin, Germany, 12351
Contact: Maike De Wit, Prof. Dr. med.         
Charité Universitätsmedizin Berlin Campus Virchow Klinikum Recruiting
Berlin, Germany, 13353
Contact: Jörg Westermann, PD Dr.         
Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum Recruiting
Bochum, Germany, 44892
Contact: Wolf Schmiegel, Prof. Dr.         
Universitätsklinikum Bonn Recruiting
Bonn, Germany, 53105
Contact: Dominik Wolf, Prof.Dr.         
Städtisches Klinikum Braunschweig Recruiting
Braunschweig, Germany, 38114
Contact: Jürgen Krauter, Prof. Dr.         
Klinikum Bremen-Mitte gGmbH Recruiting
Bremen, Germany, 28177
Contact: Bernd Hertenstein, Prof. Dr. med.         
Klinikum Darmstadt Recruiting
Darmstadt, Germany, 64283
Contact: Helga Bernhard, Prof. Dr. med.         
St. Johannes Hospital Recruiting
Dortmund, Germany, 44137
Contact: Darina Kodzahbasheva, Dr.         
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany, 40225
Contact: Thomas Schroeder, PD Dr.         
Kliniken Essen-Süd Evang. Krankenhaus Essen-Werden gGmbH Recruiting
Essen, Germany, 45239
Contact: Peter Reimer, Prof. Dr.         
Klinikum Esslingen GmbH Recruiting
Esslingen, Germany, 73730
Contact: Swen Wessendorf, PD Dr.         
St. Franziskus Hospital Recruiting
Flensburg, Germany, 24939
Contact: Nadezda Basara, Prof. Dr.         
Städtische Kliniken Frankfurt am Main-Höchst Recruiting
Frankfurt, Germany, 65929
Contact: Hans Günter Derigs, Prof. Dr. med.         
Medizinische Universitätsklinik Recruiting
Freiburg, Germany, 79106
Contact: Michael Lübbert, Prof. Dr.         
MVZ Osthessen Medizinisches Versorgungszentrum Recruiting
Fulda, Germany, 36043
Contact: Andrea Distelrath, Dr. med.         
Klinik der Justus-Liebig-Universität Recruiting
Gießen, Germany, 35385
Contact: Maisun Abu Samra, Dr.         
Wilhelm-Anton-Hospital gGmbH Recruiting
Goch, Germany, 47574
Contact: Volker Runde, Prof. Dr. med.         
Alb Fils Kliniken GmbH Recruiting
Göppingen, Germany, 73035
Contact: Martin Bommer, PD Dr.         
Universitätsmedizin Göttingen Recruiting
Göttingen, Germany, 37075
Contact: Gerald Wulf, Prof. Dr.         
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Walter Fiedler, Prof. Dr.         
Asklepios Klinik Altona Recruiting
Hamburg, Germany, 22763
Contact: Christian Meyer zum Büschenfelde, Prof. Dr.         
Evangelisches Krankenhaus Hamm Recruiting
Hamm, Germany, 59063
Contact: Elisabeth Lange, Dr.         
Klinikum Hanau gGmbH Recruiting
Hanau, Germany, 63450
Contact: Andrea Sendler, Dr.         
Klinikum Hannover Siloah Recruiting
Hannover, Germany, 30449
Contact: Hartmut Kirchner, PD Dr.         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Felicitas Thol, PD Dr.         
SLK-Kliniken Heilbronn GmbH Recruiting
Heilbronn, Germany, 74078
Contact: Uwe Martens, Prof. Dr.         
Marienhospital Herne Klinikum der Ruhr-Universität Bochum Recruiting
Herne, Germany, 44625
Contact: Beate Schultheis, Dr.         
Universitätsklinikum des Saarlandes Recruiting
Homburg/Saar, Germany, 66424
Contact: Michael Pfreundschuh, Prof.         
Städtisches Klinikum Karlsruhe Recruiting
Karlsruhe, Germany, 76133
Contact: Martin Bentz, Prof. Dr.         
Städtisches Krankenhaus Kiel GmbH Recruiting
Kiel, Germany, 24116
Contact: Heinz Horst, Prof. Dr.         
Caritas Krankenhaus Lebach Recruiting
Lebach, Germany, 66822
Contact: Stephan Kremers, Dr. med.         
Klinikum Lippe-Lemgo Recruiting
Lemgo, Germany, 32657
Contact: Frank Hartmann, Prof. Dr. med.         
Klinikum Lüdenscheid Recruiting
Lüdenscheid, Germany, 58515
Contact: Gerhard Heil, Prof. Dr.         
Univ-Klinikum der Otto-von-Guericke-Universität Recruiting
Magdeburg, Germany, 39120
Contact: Thomas Heinicke, Dr.         
Universitätsklinikum der Johannes Gutenberg-Universität Mainz Recruiting
Mainz, Germany, 55131
Contact: Thomas Kindler, Dr.         
Johannes Wesling Klinikum Minden Recruiting
Minden, Germany, 32429
Contact: Hans-Joachim Tischler, Dr.         
Klinikum Schwäbisch-Gmünd Recruiting
Mutlangen, Germany, 73557
Contact: Holger Hebart, Prof. Dr. med.         
Klinikum Schwabing Recruiting
München, Germany, 80804
Contact: Sabine Struve, Dr.         
Klinikum rechts der Isar der TU München Recruiting
München, Germany, 81675
Contact: Katharina Götze, Prof. Dr.         
Städtische Kliniken Neuss Lukaskrankenhaus GmbH Recruiting
Neuss, Germany, 41464
Contact: Ali-Nuri Hünerlitürkoglu, Dr.         
Ortenau Klinikum, Offenburg-Gengenbach Recruiting
Offenburg, Germany, 77654
Contact: Andreas Jakob, Dr.         
Pius Hospital Oldenburg Recruiting
Oldenburg, Germany, 26121
Contact: Frank Griesinger, Prof. Dr.         
Klinikum Oldenburg gGmbH Recruiting
Oldenburg, Germany, 26133
Contact: Doris Kraemer, Prof. Dr.         
Klinikum Passau Recruiting
Passau, Germany, 94032
Contact: Thomas Südhoff, Prof. Dr.         
Klinikum Vest Recruiting
Recklinghausen, Germany, 45657
Contact: Otto Kloke, Prof. Dr.         
Universitätsklinikum Recruiting
Regensburg, Germany, 93053
Contact: Simone Thomas, Dr. med.         
Akademisches Lehrkrankenhaus des Saarlandes St. Theresia Recruiting
Saarbrücken, Germany, 66113
Contact: Oliver Schmah, Dr.         
Klinikum Stuttgart Katharinenhospital Recruiting
Stuttgart, Germany, 70174
Contact: Jan Schleicher, Dr. med.         
Diakonie-Klinikum Stuttgart Recruiting
Stuttgart, Germany, 70176
Contact: Jochen Greiner, Prof. Dr.         
Vinzenz von Paul Kliniken gGmbH Marienhospital Stuttgart Recruiting
Stuttgart, Germany, 70199
Contact: Claudio Denzlinger, Prof. Dr.         
Klinikum Traunstein Recruiting
Traunstein, Germany, 83278
Contact: Thomas Kubin, Dr. med.         
Klinikum Mutterhaus der Borromäerinnen gGmbH Recruiting
Trier, Germany, 54290
Contact: Rolf Mahlberg, Dr. med.         
Krankenhaus der Barmherzigen Brüder Trier Recruiting
Trier, Germany, 54292
Contact: Heinz Kirchen, Dr.         
Medizinische Universitätsklinik Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Helmut R. Salih, Prof. Dr. med.         
University Hospital of Ulm Recruiting
Ulm, Germany, 89081
Contact: Hartmut Döhner, Prof. Dr.    49-731-500-45501    hartmut.doehner@uniklinik-ulm.de   
Universitätsklinik Ulm Labor für Zytogenetische und Molekulare Diagnostik Recruiting
Ulm, Germany, 89081
Contact: Konstanze Döhner, Prof. Dr.         
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Recruiting
Villingen-Schwenningen, Germany, 78052
Contact: Paul Graf La Rosee, Prof. Dr.         
Helios Klinikum Wuppertal Recruiting
Wuppertal, Germany, 42283
Contact: Konstantin Koutcher, Dr.         
Sponsors and Collaborators
University of Ulm
Investigators
Study Chair: Hartmut Döhner, Prof. Dr. University Hospital of Ulm

Responsible Party: Prof. Dr. Hartmut Doehner, Prof. Dr., University of Ulm
ClinicalTrials.gov Identifier: NCT01252485     History of Changes
Other Study ID Numbers: AMLSG BiO
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017

Keywords provided by Prof. Dr. Hartmut Doehner, University of Ulm:
AML
Registry study
Biology and Outcome
Higher Risk MDS

Additional relevant MeSH terms:
Syndrome
Leukemia
Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions