Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00006035

Trial Description

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Title

German MPN-Registry for BCR-ABL1-Negative Myeloid Neoplasms of the German Study Group MPN (GSG-MPN)

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Trial Acronym

GSG-MPN-Registry

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URL of the Trial

https://www.cto-im3.de/gsgmpn/

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Brief Summary in Lay Language

Myeloproliferative neoplasms (MPN) represent a very heterogeneous group of chronic hematologic diseases. Close collaboration and scientific exchange between the study centers is essential, due both to the rareness of the disease subtypes and the abundance of recent innovations in the field. The registry focuses on patient-centered care and the quality of life of patients with MPN. Due to its non-interventional character, it allows to include all patients with MPN, even those that may fail inclusion criteria of other clinical trials (i.e. due to significant comorbidities). The registry ensures a close collaboration between the participating centers, and furthermore, it aims at fostering evidence-based medicine by providing a network of physicians experienced in MPN diagnosis and therapy. At the beginning of this year, the fusion of both huge german MPN study groups (MPN-SAL and MPNSG) to the German Study Group MPN (GSG-MPN) was performed. Basis for this study group is this common MPN registry. Both registry protocols were adjusted accordingly (names, contents).

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Brief Summary in Scientific Language

The GSG-MPN-Registry is a non-interventional prospective study with longitudinal patient recruitment (different time points for patients to enter the registry). All patients who meet the WHO criteria for BCR-ABL1-negative MPN, who are at least 18 years of age, and have given written informed consent can be included. Explicitly, patients with comorbidities who are not able to participate in an interventional study should be included into the registry.

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Organizational Data

  •   DRKS00006035
  •   2014/03/31
  •   [---]*
  •   yes
  •   Approved
  •   127/12 Aachen und 100/13 Ulm, Federführende Ethikkommissionen der Universitäten in Aachen und Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   Myeloproliferatiev disorders:
    - Polycythemia vera
    - Primary and secondary myelofibrosis
    - Essential Thrombocythemia
    - Chronic eosinophilic leukemia
    - Hypereosinophilic syndrome
    - Systemic Mastocytosis
    - Chronic neutrophilic leukemia
    - Myeloproliferative disorder with eosinophilia and PDGFR-alpha-, PDGFR-beta- or FGFR1-Abberation
    - Unclassified myeloproliferative disorder
    - MDS/MPN-overlap syndromes
  •   D45 -  Polycythaemia vera
  •   D47.3 -  Essential (haemorrhagic) thrombocythaemia
  •   D47.4 -  Osteomyelofibrosis
  •   D47.0 -  Histiocytic and mast cell tumours of uncertain and unknown behaviour
  •   D47.1 -  Chronic myeloproliferative disease
  •   D47.5 -  Chronic eosinophilic leukaemia [hypereosinophilic syndrome]
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Interventions/Observational Groups

  •   In this observational study patients with MPN will be explored by assessing and evaluating their epidemiological and clinical data (symptoms, laboratory diagnostic). Additionally the quality of life will be assessed using a valid questionnaire (MPN-SAF).
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

- Morphological and genetic diagnostics i.a. at date of diagnosis and during therapy
- Asservation of bone marrow and peripheral blood, plasma, and germline material
- Assessment of epidemiological data: age, prognostic factors, distribution of subgroups. Incidence and distribution of age are compared to the population based cancer registry.
- Assessment of the most important clinical outcomes: overall survival (OS), quality of life via questionnaire (MPN-SAF).

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Secondary Outcome

- Assessment of further clinical outcomes: overall response rate (ORR), death-related morbidity (DRM), transfromation rate (TR).
- Assessment and evaluation of the quality of therapy and diagnosis via quality indicators.
- Validation of published prognostic factors and the search for possible new prognostic factors.
- Correlation of clinical endpoints with the chosen therapy regime.
- Assemement and description of new therapy regimes and new supportive care.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2013/09/02
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  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Diagnosis of a BCR-ABL1-negative MPN referring to WHO criteria and MPN with PDGFR-alpha-, PDGFR-beta-, or FGFR1-Aberration
- 18 years or older
- Written informed consent

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Exclusion Criteria

- < 18 years of age
- BCR-ABL1-positive chronic myeloid leukemia

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Addresses

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    • Klinik für Hämatologie, Onkologie, Hämostaseologie und SZT, Uniklinik RWTH Aachen
    • Mr.  Prof. Dr. med.  Steffen  Koschmieder 
    • Pauwelsstrasse 30
    • 52074  Aachen
    • Germany
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    • Klinik für Innere Medizin III, Universitätsklinikum Ulm
    • Ms.  Prof. Dr.  Konstanze  Döhner 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    • Klinik für Hämatologie, Onkologie, Hämostaseologie und SZT, Uniklinik RWTH Aachen
    • Mr.  Prof. Dr.  Steffen  Koschmieder 
    • Pauwelsstraße 30
    • 52074  Aachen
    • Germany
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    • Klinik für Innere Medizin, Universitätsklinikum Ulm
    • Ms.  Prof. Dr. med.  Konstanze  Döhner 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    • Klinik für Hämatologie, Onkologie, Hämostaseologie und SZT, Uniklinik RWTH Aachen
    • Ms.  Sabrina  Holst 
    • Pauwelsstrasse 30
    • 52074  Aachen
    • Germany
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    • Klinik für Innere Medizin III, Universitätsklinikum Ulm
    • Ms.  Regina  Reim 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    • Klinik für Innere Medizin III, Universitätsklinikum Ulm
    • Ms.  Katrin  Vetter 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Hämatologie, Onkologie und Stammzelltransplantation
    • Pauwelsstrasse 30
    • 52074  Aachen
    • Germany
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    • Klinik für Innere Medizin III Universitätsklinikum Ulm
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    • Einmalige AnschubfinanzierungNovartis Pharma
    • Roonstrasse 25
    • 90429  Nürnberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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