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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00662090

Acronym

EWOG MDS 2006

Enrollment

260

Registered

2008-04-21

Start date

2010-04-01

Completion date

2027-12-01

Last updated

2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile Myelomonocytic Leukemia, Myelodysplastic Syndromes

Keywords

MDS, JMML, EWOG-MDS, Myelodysplastic Syndromes (MDS), Juvenile Myelomonocytic Leukemia (JMML)

Brief summary

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

Healthy volunteers

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

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).

Design outcomes

Primary

Measure	Time frame
To evaluate the frequency of the different subtypes of MDS in childhood and adolescence by a standardized diagnostic approach	5 years
To evaluate the frequency of cytogenetic and molecular abnormalities	5 years

Secondary

Measure	Time frame
To assess survival for children and adolescents with MDS and JMML	5 years
To evaluate relapse rate, morbidity and mortality in children with MDS and JMML treated by HSCT	5 years

Countries

Germany

Contacts

CONTACTCharlotte M. Niemeyer, M.D.

charlotte.niemeyer@uniklinik-freiburg.de49-761-270

PRINCIPAL_INVESTIGATORCharlotte M. Niemeyer, M.D.

University of Freiburg

Outcome results