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
  Purpose

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
Myelodysplastic Syndromes
Juvenile Myelomonocytic Leukemia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 260
Study Start Date: January 2006
Estimated Study Completion Date: October 2010
  Eligibility

Ages Eligible for Study:   up to 215 Months
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662090

Contacts
Contact: Charlotte M. Niemeyer, M.D. 49-761-270 ext 4506 charlotte.niemeyer@uniklinik-freiburg.de

Locations
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
Principal Investigator: Charlotte M. Niemeyer, M.D. University of Freiburg
  More Information

Additional Information:
No publications provided by University Hospital Freiburg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charlotte Niemeyer, M.D., University Hospital of Freiburg,
ClinicalTrials.gov Identifier: NCT00662090     History of Changes
Obsolete Identifiers: NCT00898339
Other Study ID Numbers: EWOG MDS 2006
Study First Received: April 17, 2008
Last Updated: February 3, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Freiburg:
MDS
JMML
EWOG-MDS
Myelodysplastic Syndromes (MDS)
Juvenile Myelomonocytic Leukemia (JMML)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Precancerous Conditions

ClinicalTrials.gov processed this record on October 23, 2014