Study for Epidemiology and Characterization of Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leucemia (JMML) in Childhood (EWOG MDS 2006)
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| ClinicalTrials.gov Identifier: NCT00662090 |
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Recruitment Status :
Recruiting
First Posted : April 21, 2008
Last Update Posted : May 18, 2022
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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
| Condition or disease |
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| Myelodysplastic Syndromes Juvenile Myelomonocytic Leukemia |
| Study Type : | Observational |
| Estimated Enrollment : | 260 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Prospective Non-randomized Multi-center Study for Epidemiology and Characterization of Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leucemia (JMML) in Childhood |
| Study Start Date : | January 2006 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | December 2023 |
- To evaluate the frequency of the different subtypes of MDS in childhood and adolescence by a standardized diagnostic approach [ Time Frame: 5 years ]
- To evaluate the frequency of cytogenetic and molecular abnormalities [ Time Frame: 5 years ]
- To assess survival for children and adolescents with MDS and JMML [ Time Frame: 5 years ]
- To evaluate relapse rate, morbidity and mortality in children with MDS and JMML treated by HSCT [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA
At diagnosis, prior to HSCT and at relapse material form peripheral blood and bone marrow will be retrieved and stored for research purposes. If there are other diagnostic bone marrow examinations at other time points (prior to HSCT), the material will be handled the same way.
The following material will be retrieved:
- 8 smears from PB
- 8 smears from BM
- at least 5 ml of heparinized PB
- at least 5 ml of heparinized BM
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| Ages Eligible for Study: | up to 215 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662090
| Contact: Charlotte M. Niemeyer, M.D. | 49-761-270 ext 45060 | charlotte.niemeyer@uniklinik-freiburg.de |
| Germany | |
| University Hospital of Freiburg | Recruiting |
| Freiburg, Baden-Württemberg, Germany, 79106 | |
| Contact: Charlotte M. Niemeyer, M.D. 49-761-270 ext 4506 charlotte.niemeyer@uniklinik-freiburg.de | |
| Principal Investigator: Charlotte M. Niemeyer, M.D. | |
| Principal Investigator: | Charlotte M. Niemeyer, M.D. | University of Freiburg |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Charlotte Niemeyer, MD, Prof. Dr. Charlotte Niemeyer, MD, University Hospital Freiburg |
| ClinicalTrials.gov Identifier: | NCT00662090 |
| Obsolete Identifiers: | NCT00898339 |
| Other Study ID Numbers: |
EWOG MDS 2006 |
| First Posted: | April 21, 2008 Key Record Dates |
| Last Update Posted: | May 18, 2022 |
| Last Verified: | May 2022 |
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MDS JMML EWOG-MDS Myelodysplastic Syndromes (MDS) Juvenile Myelomonocytic Leukemia (JMML) |
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Preleukemia Leukemia, Myelomonocytic, Juvenile Myelodysplastic Syndromes Syndrome Disease Pathologic Processes Leukemia |
Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Leukemia, Myeloid Myelodysplastic-Myeloproliferative Diseases |