PLEASE NOTE:
This trial has been registered retrospectively.
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Trial Description
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Title
Diagnostics and therapy of patients with Diamond-Blackfan anemia (DBA)
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Trial Acronym
DBA 2000
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URL of the Trial
http://www.uniklinik-freiburg.de/kinderklinik/live/fachabteilungen/klinik4/was/dba.html?weiterleitung=ja
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Brief Summary in Lay Language
n/a
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Brief Summary in Scientific Language
n/a
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Organizational Data
DRKS-ID:
DRKS00004563
Date of Registration in DRKS:
2013/05/21
Date of Registration in Partner Registry or other Primary Registry:
[---]*
Investigator Sponsored/Initiated Trial (IST/IIT):
yes
Ethics Approval/Approval of the Ethics Committee:
Approved
(leading) Ethics Committee No.:
205/99, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs
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Health Condition or Problem studied
ICD10:
D61.0 -
Constitutional aplastic anaemia
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Interventions/Observational Groups
Arm 1:
Registration of all patients with Diamond-Blackfan anemia in germany. Retrospective data collection of implemented diagnostics, therapy and therapy- related complications. Prospective data collection of clinical course diagnostics, ongoing therapy and progress of disease. Application of existing therapy guidelines. As a result of this optimizing diagnostics and therapy, improving quality of life and long-term prognosis of patients with Diamond-Blackfan anemia. Verifying these guidelines concerning therapy efficiency.
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Characteristics
Study Type:
Non-interventional
Study Type Non-Interventional:
Epidemiological study
Allocation:
Single arm study
Blinding:
Open (masking not used)
Who is blinded:
[---]*
Control:
Uncontrolled/Single arm
Purpose:
Diagnostic
Assignment:
Single (group)
Phase:
N/A
Off-label Drug use:
N/A
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Primary Outcome
Registration of all patients with Diamond-Blackfan anemia in germany. Retrospective data collection of implemented diagnostics, therapy and therapy- related complications. Prospective data collection of clinical course diagnostics, ongoing therapy and progress of disease. Application of existing therapy guidelines. As a result of this optimizing diagnostics and therapy, improving quality of life and long-term prognosis of patients with Diamond-Blackfan anemia. Verifying these guidelines concerning therapy efficiency.
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Secondary Outcome
Moleculargenetic analyses to identify underlying genetic defects. Genotype-phenotype-studies about pathophysiology of DBA disease. Identification of patients with DBA to be in line for experimental therapy questions. Therefor there will be set up separate therapy protocols. Support of patient network „DBA-Gemeinschaft (community)“ and informing affected families about diagnostics and therapy.
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Countries of Recruitment
DE:
Germany
CH:
Switzerland
AT:
Austria
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Locations of Recruitment
University Medical Center
Kinderklinik der RWTH,
Aachen
Medical Center
Kinderklinik des KZVA,
Augsburg
Medical Center
Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie, Charité-Universitätsmedizin Berlin,
Berlin
Medical Center
Ev. Krankenhaus Bielefeld gGmbH,
Bielefeld
University Medical Center
Abteilung für Pädiatrische Hämatologie und Onkologie, Zentrum für Kinderheilkunde des Universitätsklinikums Bonn,
Bonn
Medical Center
Städtisches Krankenhaus, Kinderklinik,
Braunschweig
Medical Center
Klinikum Bremen-Mitte, Prof.-Hess-Kinderklinik,
Bremen
Medical Center
Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin,
Chemnitz
University Medical Center
Carl-Thiem-Klinikum, Kinder- und Jugendmedizin,
Cottbus
University Medical Center
Vestische Kinderklinik der Uni Witten/Herdecke,
Datteln
Medical Center
Klinikum Dortmund gGmbH,
Dortmund
University Medical Center
Universitätsklinikum Carl Gustav Carus,
Dresden
University Medical Center
Klinik für Pädiatrische Hämatologie und Onkologie, Medizinische Einrichtungen der Heinrich-Heine Universität,
Düsseldorf
Medical Center
Helios Klinikum Erfurt, Klinik für Kinderheilkunde,
Erfurt
University Medical Center
Klinik für Kinder und Jugendliche der Uni Erlangen-Nürnberg,
Erlangen
University Medical Center
Universitätsklinikum Essen, Kinderklinik,
Essen
University Medical Center
Zentrum für Kinderheilkunde und Jugendmedizin, Klinik für Kinderheilkunde III,
Frankfurt a.M.
University Medical Center
Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik IV, Pädiatrische Hämatologie/Onkologie,
Freiburg im Breisgau
University Medical Center
Universitätsklinikum Gießen und Marburg,
Gießen
University Medical Center
Universitäts-Kinderklinik,
Göttingen
University Medical Center
Klinikum Greifswald, Abteilung Pädiatrische Onkologie und Hämatologie,
Greifswald
University Medical Center
Klinik für Kinderheilkunde der Martin-Luther-Universität,
Halle Saale
University Medical Center
Universitätsklinikum Hamburg Eppendorf, Klinik und Poliklinik für Pädiatrische Hämatologie und Onkologie,
Hamburg
University Medical Center
Medizinische Hochschule Hannover, Kinderheilkunde, Pädiatrische Hämatologie und Onkologie,
Hannover
University Medical Center
Universitäts-Kinderklinik,
Heidelberg
Medical Center
Gemeinschaftskrankenhaus Herdecke, Kinderabteilung,
Herdecke
University Medical Center
Universitätsklinik für Kinder- und Jugendmedizin,
Homburg/Saar
University Medical Center
Klinik für Kinder- und Jugendmedizin der Freidrich-Schiller-Universität,
Jena
Medical Center
Klinik für Kinder- und Jugendmedizin, Städtisches Klinikum Karlsruhe,
Karlsruhe
Medical Center
Klinikum Kassel, Klinik für Pädiatrische Hämatologie und Onkologie,
Kassel
University Medical Center
Klinik für Allgemeine Pädiatrie, Universitäts-Kinderklinik,
Kiel
Medical Center
Städtisches Krankenhaus Kemperhof, Kinderklinik,
Koblenz
University Medical Center
Universitätsklinik Köln, Kinderonkologie und -hämatologie,
Köln
Medical Center
Kliniken der Stadt Köln, Kinderkrankenhaus Amsterdamer Straße,
Köln
Medical Center
Klinikum Krefeld, Kinderklinik,
Krefeld
University Medical Center
Universitätsklinikum Leipzig, Abteilung für Pädiatrische onkologie, Hämatologie und Hämostaseologie,
Leipzig
University Medical Center
Medizinische Universität zu Lübeck, Klinik für Pädiatrie,
Lübeck
University Medical Center
Zentrum für Kinderheilkunde der Otto-von-Guericke-Universität,
Magdeburg
University Medical Center
Kinderklinik der Universität Mainz, Onko-Hämatologie,
Mainz
University Medical Center
Klinikum der Stadt Mannheim, Kinderklinik,
Aachen
University Medical Center
Universitätsklinikum Marburg und Giessen,
Marburg
University Medical Center
Klinik und Poliklinik für Kinder- und Jugendmedizin der TU München, Klinikum Schwabing StKM ,
München
Medical Center
Kinderklinik und Kinderpoliklinik im Dr. von Haunerschen Kinderspital,
München
University Medical Center
Westfälische Wilhelms-Universität, Klinik für Kinderheilkunde,
Münster
Medical Center
Cnopf´sche Kinderklinik,
Nürnberg
Medical Center
Klinikum Oldenburg, Klinik für Allgemeine Kinderheilkunde, Hämatologie/Onkologie,
Oldenburg
University Medical Center
Universitätsklinikum Regensburg KUNO (Kinderklinik Ostbayern),
Regensburg
University Medical Center
Universitäts-Kinder-und Jugendklinik, Abteilung Allg. Pädiatrie/Onkologie,
Rostock
Medical Center
Asklepios Kinderklinik Sankt Augustin,
Sankt Augustin
Medical Center
Deutsches Rotes Kreuz, Kinderklinik,
Siegen
University Medical Center
Klinikum Stuttgart, Olgahospital, klinik für Kinderheilkunde und Jugendmedizin - Pädiatrie 5,
Stuttgart
Medical Center
Klinikum Trier, Mutterhaus der Borromäerinnen,
Trier
University Medical Center
Universitäts-Kinderklinik, Abt. Kinderheilkunde I,
Tübingen
University Medical Center
Universitäts-Kinder und Poliklinik,
Ulm
University Medical Center
Universitätsklinik für Kinder- und Jugendheilkunde,
Graz
University Medical Center
Universitätsklinik für Kinder- und Jugendheilkunde,
Innsbruck
Medical Center
Landeskrankenhaus, Abt. für Kinder- und Jugendheilkunde,
Klagenfurt
Medical Center
Kinderklinik, Kinder- und Jugendheilkunde, Onkologie,
Linz
Medical Center
St. Johanns Spital/LKH,
Salzburg
Medical Center
St. Anna Kinderspital,
Wien
University Medical Center
Universitätsklinik für Kinder und Jugendheilkunde,
Wien
Medical Center
Kantonsspital,
Aarau
University Medical Center
Universitäts-Kinderspital Beider Basel,
Basel
Medical Center
Ente Ospedaliero Cantonale,
Bellinzona
Medical Center
Inselspital Bern,
Bern
University Medical Center
CHUV (Centre hospitalier universitaire vaudois),
Lausanne
Medical Center
Kinderspital,
Luzern
Medical Center
Ostschweizerisches Kinderspital,
St. Gallen
University Medical Center
Universitäts-Kinderklinik,
Zürich
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Recruitment
Planned/Actual:
Actual
(Anticipated or Actual) Date of First Enrollment:
2000/12/01
Target Sample Size:
200
Monocenter/Multicenter trial:
Multicenter trial
National/International:
International
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Inclusion Criteria
Gender:
Both, male and female
Minimum Age:
no minimum age
Maximum Age:
no maximum age
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Additional Inclusion Criteria
diagnosed Diamond-Blackfan-Anemia, patient informed consent
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Exclusion Criteria
none
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Addresses
Primary Sponsor
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Universitätsklinikum Freiburg, ZKJ, Pädiatrische Hämatologie/Onkologie, Klinik IV
Ms.
Prof. Dr. med
Charlotte
Niemeyer
Mathildenstr. 1
79106
Freiburg
Germany
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Contact for Scientific Queries
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Universitätsklinikum Freiburg, ZKJ, Pädiatrische Hämatologie/Onkologie, Klinik IV
Ms.
Prof. Dr. med
Charlotte
Niemeyer
Mathildenstr. 1
79106
Freiburg
Germany
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Contact for Public Queries
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Universitätsklinikum Freiburg, ZKJ, Pädiatrische Hämatologie/Onkologie, Klinik IV
Ms.
Prof. Dr. med
Charlotte
Niemeyer
Mathildenstr. 1
79106
Freiburg
Germany
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Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
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Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin, Klinik IV, Pädiatrische Hämatologie/Onkologie
Mathildenstr. 1
79106
Freiburg
Germany
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Status
Recruitment Status:
Recruiting ongoing
Study Closing (LPLV):
[---]*
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Trial Publications, Results and other Documents
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