Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003789

Trial Description

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Title

Prospective Non-randomized Multi-center Study for Epidemiology and Characterization of Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leucemia (JMML) in Childhood

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Trial Acronym

EWOG MDS 2006

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URL of the Trial

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Brief Summary in Lay Language

The aim of the study is to improve the accuracy of diagnosis for children and adolescents
with MDS by a standardized review of morphology and standardized cytogenetic and molecular
analysis.

The primary objectives of the study are:

- To evaluate the frequency of the different subtypes of MDS in childhood and adolescence
by a standardized diagnostic approach

- To evaluate the frequency of cytogenetic and molecular abnormalities:

Specifically using array-CGH to evaluate the frequency of subtle chromosomal imbalances,
i.e. gains and losses of defined chromosomal regions, and amplifications.

Specifically using mFISH to identify unknown chromosomal aberrations, particularly subtle
translocations involving new candidate genes, and to better define chromosomal breakpoints.

The secondary objectives of the study are:

- To assess survival for children and adolescents with MDS and JMML

- To evaluate relapse rate, morbidity and mortality in children with MDS and JMML treated
by HSCT

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003789
  •   2012/05/04
  •   2008/04/17
  •   yes
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Secondary IDs

  •   NCT00662090  (ClinicalTrials.gov)
  •   EWOG MDS 2006  (University Hospital Freiburg)
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Health Condition or Problem studied

  •   Myelodysplastic Syndromes
  •   Juvenile Myelomonocytic Leukemia
  •   D46 -  Myelodysplastic syndromes
  •   C93.3 -  Juvenile myelomonocytic leukaemia
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Interventions/Observational Groups

  • [---]*
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- To evaluate the frequency of the different subtypes of MDS in childhood and adolescence by a standardized diagnostic approach; time frame: 5 years
- To evaluate the frequency of cytogenetic and molecular abnormalities; time frame: 5 years

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Secondary Outcome

- To assess survival for children and adolescents with MDS and JMML; time frame: 5 years
- To evaluate relapse rate, morbidity and mortality in children with MDS and JMML treated by HSCT; time frame: 5 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2006/01/31
  •   260
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   215   Months
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Additional Inclusion Criteria

- Written informed consent by the caretakers and whenever possible the patient's
assent.

- Confirmed diagnosis of MDS or JMML (morphology, cytogenetics)

- Myeloid leukemia of Down syndrome (patients aged > 6 years).

- Age less than 18 years

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Exclusion Criteria

- Denied informed consent and/or assent by caretakers/patient.

- Myeloid leukemia of Down syndrome (patients < 6 years).

- Participation in another study within the last 4 weeks (except for therapy
optimizing studies in cancer or bone marrow failure disorders and studies in
diagnostics).

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Addresses

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    • University Hospital Freiburg
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    • University of Freiburg
    • Charlotte M. Niemeyer, M.D. 
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    • Charlotte M. Niemeyer, M.D. 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   311
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.