Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - The Biology and Outcome (BiO)-Project
- Conditions
- Acute Myeloid Leukemia (AML)MDS/AML
- Registration Number
- NCT01252485
- Lead Sponsor
- University of Ulm
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50000
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of disease-related genetic markers 4 weeks To perform rapid analyses of disease-related genetic markers (according to International Consensus Classification 2022) (incidences, treatment recommendations)
Event-free survival 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 \[OS\])
Cumulative incidence of relapse 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 \[OS\])
Cumulative incidence of death 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 \[OS\])
Overall survival 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 \[OS\])
Treatment decision (intensive, non-intensive, investigational) 1 year To perform rapid analyses of disease-related genetic markers (according to ICC 2022) (incidences, treatment recommendations)
quality of life 2 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), 6, 12 and 24 months after registration.
Geographical representation 1 day Geographical representation of patients through collection of patients zip codes
Response to therapy 1 year Rate of response: complete remission (CR), CR with partial hematologic recovery (CRh); CR with incomplete hematologic recovery (CRi)
Relapse-free survival 10 years Measurable residual disease (MRD) 10 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (90)
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Marien Hospital Düsseldorf GmbH
🇩🇪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
Universitätsmedizin Greifswald
🇩🇪Greifswald, Germany
Alb Fils Kliniken GmbH
🇩🇪Göppingen, Germany
Universitätsmedizin Göttingen
🇩🇪Göttingen, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Asklepios Klinik Altona
🇩🇪Hamburg, Germany
Asklepios Kliniken Hamburg GmbH St. Georg
🇩🇪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
Städtisches Klinikum Karlsruhe
🇩🇪Karlsruhe, Germany
St. Vincentius-Kliniken 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
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
🇩🇪Ludwigshafen, Germany
Universitätslinikum Schleswig-Holstein, Lübeck
🇩🇪Lübeck, Germany
Klinikum Lüdenscheid
🇩🇪Lüdenscheid, Germany
Univ-Klinikum der Otto-von-Guericke-Universität
🇩🇪Magdeburg, Germany
Klinikum Magdeburg gGmbH
🇩🇪Magdeburg, Germany
Universitätsklinikum der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Klinikum Hochsauerland GmbH
🇩🇪Meschede, Germany
Johannes Wesling Klinikum Minden
🇩🇪Minden, Germany
Klinikum Schwäbisch-Gmünd
🇩🇪Mutlangen, Germany
Evangelisches Krankenhaus Mülheim an der Ruhr GmbH
🇩🇪Mühlheim, Germany
Klinikum Schwabing
🇩🇪München, Germany
Klinikum rechts der Isar der TU München
🇩🇪München, Germany
Städtische Kliniken Neuss Lukaskrankenhaus GmbH
🇩🇪Neuss, Germany
Sana Klinikum Offenbach
🇩🇪Offenbach, Germany
Ortenau Klinikum, Offenburg-Gengenbach
🇩🇪Offenburg, Germany
Pius Hospital Oldenburg
🇩🇪Oldenburg, Germany
Klinikum Oldenburg gGmbH
🇩🇪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
Klinikum Stuttgart Katharinenhospital
🇩🇪Stuttgart, Germany
Diakonie-Klinikum Stuttgart
🇩🇪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
University Hospital of Ulm
🇩🇪Ulm, Germany
Universitätsklinik Ulm Labor für Zytogenetische und Molekulare Diagnostik
🇩🇪Ulm, Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
🇩🇪Villingen-Schwenningen, Germany
Harzklinikum Dorothea Christiane Erxleben
🇩🇪Wernigerode, Germany
Helios Klinikum Wuppertal
🇩🇪Wuppertal, Germany
Medizinische Universität Graz
🇦🇹Graz, Austria
Medizinische Universität Innsbruck
🇦🇹Innsbruck, Austria
Krankenhaus der Barmherzigen Schwestern Linz Betriebsgesellschaft m.b.H.
🇦🇹Linz, Austria
Krankenhaus der Elisabethinen Linz GmbH
🇦🇹Linz, Austria
Kepler Universitätsklinikum GmbH
🇦🇹Linz, Austria
Landeskrankenhaus Feldkirch
🇦🇹Rankweil, Austria
Universitätsklinikum der PMU Landeskrankenhaus Salzburg
🇦🇹Salzburg, Austria
Hanuschkrankenhaus Wien
🇦🇹Wien, Austria
Klinikum Aschaffenburg
🇩🇪Aschaffenburg, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
Ubbo-Emmius-Klinik Aurich
🇩🇪Aurich, Germany
Helios Klinikum Bad Saarow
🇩🇪Bad Saarow, Germany
Vivantes Klinikum am Urban
🇩🇪Berlin, Germany
Vivantes Netzwerk für Gesundheit GmbH Klinikum Neukölln
🇩🇪Berlin, Germany
Charité Universitätsmedizin Berlin Campus Virchow Klinikum
🇩🇪Berlin, Germany
Vivantes Klinikum Spandau
🇩🇪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