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

Recruiting now

Conditions studied: Myelodysplastic Syndromes, Juvenile Myelomonocytic Leukemia

In brief

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

Key facts

Study ID

NCT00662090

Run by

University Hospital Freiburg

People needed

260

Starts

2010-04-01

Expected to finish

2027-12-01

Last updated by the study team

2026-05-04

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• University Hospital of Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany (enrolling)

Full record on ClinicalTrials.gov

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