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Study for Epidemiology and Characterization of Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leucemia (JMML) in Childhood

Study acronym: EWOG MDS 2006
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Trial status: Active, Not Recruiting to Recruitingv12 Show 4 more changesShow less
    • Primary completion date: Dec 2023 to Dec 2027
    • Start date: Jan 2006 to Apr 2010
    • Study completion date: Dec 2024 to Dec 2027
    • Site details revised
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v11
  3. Notable Primary completion date: Dec 2022 to Dec 2023
    • Study completion date: Dec 2023 to Dec 2024
    v10
  4. Notable Primary completion date: Dec 2021 to Dec 2022
    • Study completion date: Dec 2021 to Dec 2023
    v9
  5. Notable Primary and study completion dates: Dec 2019 to Dec 2021v8
Show 6 earlier versionsHide 6 earlier versions
  1. Notable Primary and study completion dates: Dec 2018 to Dec 2019v7
  2. Minor Re-verified, no change to tracked fieldsv6
  3. Notable Primary and study completion dates: Dec 2016 to Dec 2018v5
  4. Notable Primary and study completion dates: Jun 2015 to Dec 2016v4
  5. Minor Primary completion date: Jun 2015
    • Study completion date: Oct 2010 to Jun 2015
    v3
  6. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT00662090
Lead Sponsor University Hospital Freiburg
Conditions
(from sponsor)
Myelodysplastic Syndromes, Juvenile Myelomonocytic Leukemia
Related terms Leukemia, Myelomonocytic, Juvenile, Myelodysplastic Syndromes
Enrollment 260 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov