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NCT01252485 Clinical Trial

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

Acute Myeloid Leukemia (AML) Clinical Trial

— AMLSG BiO  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01252485
Other study ID # AMLSG BiO
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 2010

Study information
Verified date May 2024
Source University of Ulm
Contact Hartmut Döhner, Prof. Dr.
Phone 49-731-500-45501
Email hartmut.doehner@uniklinik-ulm.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Medizinische Universität Graz Graz
Austria Medizinische Universität Innsbruck Innsbruck
Austria Kepler Universitätsklinikum GmbH Linz
Austria Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H. Linz
Austria Krankenhaus der Elisabethinen Linz GmbH Linz
Austria Landeskrankenhaus Feldkirch Rankweil
Austria Universitätsklinikum der PMU Landeskrankenhaus Salzburg Salzburg
Austria Hanuschkrankenhaus Wien Wien
Germany Klinikum Aschaffenburg Aschaffenburg
Germany Klinikum Augsburg Augsburg
Germany Ubbo-Emmius-Klinik Aurich Aurich
Germany Helios Klinikum Bad Saarow Bad Saarow
Germany Charité Universitätsmedizin Berlin Campus Virchow Klinikum Berlin
Germany Vivantes Klinikum am Urban Berlin
Germany Vivantes Klinikum Spandau Berlin
Germany Vivantes Netzwerk für Gesundheit GmbH Klinikum Neukölln Berlin
Germany Augusta-Kranken-Anstalt Bochum
Germany Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum Bochum
Germany Universitätsklinikum Bonn Bonn
Germany Städtisches Klinikum Braunschweig Braunschweig
Germany Klinikum Bremen-Mitte gGmbH Bremen
Germany Klinikum Darmstadt Darmstadt
Germany St. Johannes Hospital Dortmund
Germany Marien Hospital Düsseldorf GmbH Düsseldorf
Germany Universitätsklinikum Düsseldorf Düsseldorf
Germany Kliniken Essen-Süd Evang. Krankenhaus Essen-Werden gGmbH Essen
Germany Klinikum Esslingen GmbH Esslingen
Germany St. Franziskus Hospital Flensburg
Germany Städtische Kliniken Frankfurt am Main-Höchst Frankfurt
Germany Medizinische Universitätsklinik Freiburg
Germany MVZ Osthessen Medizinisches Versorgungszentrum Fulda
Germany Klinik der Justus-Liebig-Universität Gießen
Germany Wilhelm-Anton-Hospital gGmbH Goch
Germany Alb Fils Kliniken GmbH Göppingen
Germany Universitätsmedizin Göttingen Göttingen
Germany Universitätsmedizin Greifswald Greifswald
Germany Asklepios Klinik Altona Hamburg
Germany Asklepios Kliniken Hamburg GmbH St. Georg Hamburg
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg
Germany Evangelisches Krankenhaus Hamm Hamm
Germany Klinikum Hanau gGmbH Hanau
Germany Klinikum Hannover Siloah Hannover
Germany Medizinische Hochschule Hannover Hannover
Germany SLK-Kliniken Heilbronn GmbH Heilbronn
Germany Marienhospital Herne Klinikum der Ruhr-Universität Bochum Herne
Germany Universitätsklinikum des Saarlandes Homburg/Saar
Germany Westpfalz-Klinikum Kaiserslautern Kaiserslautern
Germany St. Vincentius-Kliniken Karlsruhe Karlsruhe
Germany Städtisches Klinikum Karlsruhe Karlsruhe
Germany Städtisches Krankenhaus Kiel GmbH Kiel
Germany Helios Klinikum Krefeld Krefeld
Germany Klinikum Landshut gGmbH Landshut
Germany Caritas Krankenhaus Lebach Lebach
Germany Klinikum Lippe-Lemgo Lemgo
Germany Universitätslinikum Schleswig-Holstein, Lübeck Lübeck
Germany Klinikum Lüdenscheid Lüdenscheid
Germany Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen
Germany Klinikum Magdeburg gGmbH Magdeburg
Germany Univ-Klinikum der Otto-von-Guericke-Universität Magdeburg
Germany Universitätsklinikum der Johannes Gutenberg-Universität Mainz Mainz
Germany Klinikum Hochsauerland GmbH Meschede
Germany Johannes Wesling Klinikum Minden Minden
Germany Evangelisches Krankenhaus Mülheim an der Ruhr GmbH Mühlheim
Germany Klinikum rechts der Isar der TU München München
Germany Klinikum Schwabing München
Germany Klinikum Schwäbisch-Gmünd Mutlangen
Germany Städtische Kliniken Neuss Lukaskrankenhaus GmbH Neuss
Germany Sana Klinikum Offenbach Offenbach
Germany Ortenau Klinikum, Offenburg-Gengenbach Offenburg
Germany Klinikum Oldenburg gGmbH Oldenburg
Germany Pius Hospital Oldenburg Oldenburg
Germany Klinikum Passau Passau
Germany Ernst-von-Bergmann-Klinikum Potsdam gGmbH Potsdam
Germany Klinikum Vest Recklinghausen
Germany Universitätsklinikum Regensburg
Germany Akademisches Lehrkrankenhaus des Saarlandes St. Theresia Saarbrücken
Germany Marienhaus Klinikum St. Elisaeth Saarlouis Saarlouis
Germany Nordwest-Krankenhaus Sanderbusch Sande
Germany Diakonie-Klinikum Stuttgart Stuttgart
Germany Klinikum Stuttgart Katharinenhospital Stuttgart
Germany Vinzenz von Paul Kliniken gGmbH Marienhospital Stuttgart Stuttgart
Germany Klinikum Traunstein Traunstein
Germany Klinikum Mutterhaus der Borromäerinnen gGmbH Trier
Germany Krankenhaus der Barmherzigen Brüder Trier Trier
Germany Medizinische Universitätsklinik Tübingen Tübingen
Germany Universitätsklinik Ulm Labor für Zytogenetische und Molekulare Diagnostik Ulm
Germany University Hospital of Ulm Ulm
Germany Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH Villingen-Schwenningen
Germany Harzklinikum Dorothea Christiane Erxleben Wernigerode
Germany Helios Klinikum Wuppertal Wuppertal

Sponsors (1)
Lead Sponsor Collaborator
University of Ulm

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of disease-related genetic markers To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations) 4 weeks
Primary Event-free survival 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]) 10 years
Primary Cumulative incidence of relapse 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]) 10 years
Primary Cumulative incidence of death 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]) 10 years
Primary Overall survival 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]) 10 years
Primary Treatment decision (intensive, non-intensive, investigational) To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations) 1 year
Primary quality of life 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. 5 years
Primary Geographical representation Geographical representation of patients through collection of patients zip codes 1 day
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