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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University Hospital Freiburg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00662090
First received: April 17, 2008
Last updated: February 3, 2010
Last verified: February 2010

April 17, 2008
February 3, 2010
January 2006
Not Provided
  • To evaluate the frequency of the different subtypes of MDS in childhood and adolescence by a standardized diagnostic approach [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To evaluate the frequency of cytogenetic and molecular abnormalities [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • To evaluate relapse rate, morbidity and mortality in children with MDS and JMML treated by HSCT [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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
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
October 2010
Not Provided

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).
Both
up to 215 Months
No
Contact: Charlotte M. Niemeyer, M.D. 49-761-270 ext 4506 charlotte.niemeyer@uniklinik-freiburg.de
Germany
 
NCT00662090
EWOG MDS 2006
No
Charlotte Niemeyer, M.D., University Hospital of Freiburg,
University Hospital Freiburg
Not Provided
Principal Investigator: Charlotte M. Niemeyer, M.D. University of Freiburg
University Hospital Freiburg
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP