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NCT Number: NCT00662090

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

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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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Juvenile Myelomonocytic Leukemia Leukemia Leukemia, Myeloid Leukemia, Myelomonocytic, Juvenile Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location status: Recruiting

Location contact

Charlotte M. Niemeyer, M.D.

CONTACT

[email protected]

49-761-270 ext. 4506

Charlotte M. Niemeyer, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

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

    Time frame: 5 years

  2. To evaluate the frequency of cytogenetic and molecular abnormalities

    Time frame: 5 years

Secondary outcomes

  1. To assess survival for children and adolescents with MDS and JMML

    Time frame: 5 years

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

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte M. Niemeyer, M.D.

CONTACT

[email protected]

49-761-270 ext. 45060

Sponsors and collaborators

Lead sponsor

University Hospital Freiburg

Other

Registry information

Official study title

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

Acronym: EWOG MDS 2006

Important dates

Study start
2010
Primary completion
2027
Study completion
2027
First posted
Apr 21, 2008
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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