Trial Information
Prospective Non-randomized Multi-center Study for Epidemiology and Characterization of Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leucemia (JMML) in Childhood
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).
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
To evaluate the frequency of the different subtypes of MDS in childhood and adolescence by a standardized diagnostic approach
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Charlotte M. Niemeyer, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Freiburg
Authority:
Germany: Ethics Commission
Study ID:
EWOG MDS 2006
NCT ID:
NCT00662090
Start Date:
January 2006
Completion Date:
October 2010
Related Keywords:
- Myelodysplastic Syndromes
- Juvenile Myelomonocytic Leukemia
- MDS
- JMML
- EWOG-MDS
- Myelodysplastic Syndromes (MDS)
- Juvenile Myelomonocytic Leukemia (JMML)
- Leukemia
- Myelodysplastic Syndromes
- Preleukemia
- Leukemia, Myelomonocytic, Acute
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Myelomonocytic, Juvenile