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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
Recruitment Status : Recruiting
First Posted : April 21, 2008
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Charlotte Niemeyer, MD, University Hospital Freiburg

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

Condition or disease
Myelodysplastic Syndromes Juvenile Myelomonocytic Leukemia

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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 2019
Estimated Study Completion Date : December 2019





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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


Information from the National Library of Medicine

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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
Study Population
MDS and JMML diagnosted
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).

Information from the National Library of Medicine

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


Contacts
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Contact: Charlotte M. Niemeyer, M.D. 49-761-270 ext 45060 charlotte.niemeyer@uniklinik-freiburg.de

Locations
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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.         
Sponsors and Collaborators
University Hospital Freiburg
Investigators
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Principal Investigator: Charlotte M. Niemeyer, M.D. University of Freiburg
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: April 17, 2019
Last Verified: April 2019
Keywords provided by Charlotte Niemeyer, MD, University Hospital Freiburg:
MDS
JMML
EWOG-MDS
Myelodysplastic Syndromes (MDS)
Juvenile Myelomonocytic Leukemia (JMML)
Additional relevant MeSH terms:
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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