NCT00662090 Study for Epidemiology and Characterization of Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leucemia (JMML) in Childhood
| NCT ID | NCT00662090 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Freiburg |
| Condition | Myelodysplastic Syndromes |
| Study Type | OBSERVATIONAL |
| Enrollment | 260 participants |
| Start Date | 2010-04 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 260 participants in total. It began in 2010-04 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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).
Contact & Investigator
Charlotte M. Niemeyer, M.D.
PRINCIPAL INVESTIGATOR
University of Freiburg
Frequently Asked Questions
Who can join the NCT00662090 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Myelodysplastic Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00662090 currently recruiting?
Yes, NCT00662090 is actively recruiting participants. Contact the research team at charlotte.niemeyer@uniklinik-freiburg.de for enrollment information.
Where is the NCT00662090 trial being conducted?
This trial is being conducted at Freiburg im Breisgau, Germany.
Who is sponsoring the NCT00662090 clinical trial?
NCT00662090 is sponsored by University Hospital Freiburg. The principal investigator is Charlotte M. Niemeyer, M.D. at University of Freiburg. The trial plans to enroll 260 participants.