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Study for Epidemiology and Characterization of Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leucemia (JMML) in Childhood (EWOG MDS 2006)

This study is currently recruiting participants.
Verified May 2017 by Charlotte Niemeyer, MD, University Hospital Freiburg
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662090
First Posted: April 21, 2008
Last Update Posted: May 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Charlotte Niemeyer, MD, University Hospital Freiburg
April 17, 2008
April 21, 2008
May 3, 2017
January 2006
December 2018   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00662090 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study for Epidemiology and Characterization of Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leucemia (JMML) in Childhood
Prospective Non-randomized Multi-center 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
Not Provided
Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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
Non-Probability Sample
MDS and JMML diagnosted
  • Myelodysplastic Syndromes
  • Juvenile Myelomonocytic Leukemia
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
260
December 2018
December 2018   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
up to 215 Months   (Child)
No
Contact: Charlotte M. Niemeyer, M.D. 49-761-270 ext 45060 charlotte.niemeyer@uniklinik-freiburg.de
Germany
 
 
NCT00662090
EWOG MDS 2006
No
Not Provided
Not Provided
Charlotte Niemeyer, MD, University Hospital Freiburg
University Hospital Freiburg
Not Provided
Principal Investigator: Charlotte M. Niemeyer, M.D. University of Freiburg
University Hospital Freiburg
May 2017