Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007995

Trial Description

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Title

Registry on data collected from patients with mastocytosis in Europe

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Trial Acronym

ECNM Registry

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URL of the Trial

http://ecnm.net/homepage/index.php/objectives

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Brief Summary in Lay Language

The primary goal of the ECNM Registry is to collect data from a large number of patients with mastocytosis in Europe over a longer time period (minimum 3 years) in order to learn more about the incidence, biology, pathogenesis, and course of this rare and poorly understood disease.

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Brief Summary in Scientific Language

Mastocytosis is a disease characterized by abnormal growth and accumulation of mast cells in i) the skin, ii) in internal organs, or iii) in both the skin and internal organs. Traditionally, mastocytosis is classified as being either cutaneous mastocytosis (CM) or systemic mastocytosis (SM). In cutaneous mastocytosis, mast cell accumulation is only found in the skin. The pure cutaneous form of mastocytosis is usually diagnosed in childhood. By contrast, most patients in adulthodd are diagnosed to have systemic mastocytosis.
The major aims of the ECNM Registry are to establish solid knowledge about the incidence of mastocytosis, the course of the disease, clinical presentation and course in subvariants, long term survival in various groups of patients, prognostic variables, key markers of disease stability and progression, responses and side effects of various therapies, and long term treatment effects.

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Organizational Data

  •   DRKS00007995
  •   2015/04/16
  •   [---]*
  •   yes
  •   Approved
  •   466/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   D47.0 -  Histiocytic and mast cell tumours of uncertain and unknown behaviour
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Interventions/Observational Groups

  •   Observational study to collect data from a large number of patients with mastocytosis in Europe over a longer time period (minimum 3 years) in order to learn more about the incidence, biology, pathogenesis, and course of this rare and poorly understood disease.
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Characteristics

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

· Percentage of patients in each category of mastocytosis in Europe
· Percentage of patients in each category of mastocytosis in Europe in different
European regions
· Gender and age distribution of patients with mastocytosis in Europe

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Secondary Outcome

Percentage of patients who show progression to frank aggressive mastocytosis
or AHNMD
· Time to progression
· Survival of patients with mastocytosis
· Occurrence of mediator symptoms
· Determination of risk factors predicting the progression as well as the resulting
survival and/or outcome in patients fulfilling the criteria of mastocytosis.
· Response to mediator therapy administered in routine

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/10/10
  •   2000
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

All patients with mastocytosis diagnosed since January 1990 in the participating european centers.

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Exclusion Criteria

none.

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Addresses

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    • Klinik für Innere Medizin IAbteilung für Hämatologie und HämostaseologieMedizinische Universität Wien
    • Mr.  Prof. Dr. med.  Wolfgang Reinhard  Sperr 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Germany
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    • Universitätsklinikum FreiburgMedizinische Klinik IHämatologie, Onkologie und Stammzelltransplantation
    • Mr.  Dr. med. univ.  Khalid  Shoumariyeh 
    • Hugstetter Str. 55
    • 79106  Freiburg im Breisgau
    • Germany
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    • Universitätsklinikum FreiburgMedizinische Klinik IHämatologie, Onkologie und Stammzelltransplantation
    • Mr.  Dr. med. univ.  Khalid  Shoumariyeh 
    • Hugstetter Str. 55
    • 79106  Freiburg im Breisgau
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Str. 55
    • 79104  Freiburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Klinik für Innere Medizin IAbteilung für Hämatologie und HämostaseologieMedizinische Universität Wien
    • Mr.  Prof. Dr. med.  Wolfgang Reinhard  Sperr 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.