Study for Epidemiology and Characterization of Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leucemia (JMML) in Childhood - Full Text View

Sponsored by:	University Hospital Freiburg
Information provided by:	University Hospital Freiburg
ClinicalTrials.gov Identifier:	NCT00662090

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 (MDS) Juvenile Myelomonocytic Leukemia (JMML)

MedlinePlus related topics: Leukemia, Childhood

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Prospective Non-Randomized Multi-Center Study for Epidemiology and Characterization of Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leucemia (JMML) in Childhood

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

Biospecimen 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

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

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, Baden-Württemberg
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 Hospital Freiburg

More Information

Additional Information:

Homepage of the EWOG-MDS-Study Group This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital of Freiburg, ( Charlotte Niemeyer, M.D. )
Study ID Numbers:	EWOG MDS 2006
Study First Received:	April 17, 2008
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00662090 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital Freiburg:

MDS
JMML
EWOG-MDS

Study placed in the following topic categories:

Chronic Myelomonocytic Leukemia
Precancerous Conditions
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Myeloproliferative Disorders
Juvenile Myelomonocytic Leukemia
Leukemia, Myelomonocytic, Juvenile

Leukemia, Myeloid
Leukemia, Myelomonocytic, Acute
Leukemia
Preleukemia
Bone Marrow Diseases
Myelodysplastic-Myeloproliferative Diseases
Myelodysplastic Myeloproliferative Disease

Additional relevant MeSH terms:

Disease
Neoplasms by Histologic Type
Precancerous Conditions
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Leukemia, Myelomonocytic, Juvenile
Leukemia, Myeloid

Leukemia, Myelomonocytic, Acute
Leukemia
Preleukemia
Neoplasms
Pathologic Processes
Syndrome
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases

ClinicalTrials.gov processed this record on May 07, 2009