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

Myelodysplastic Syndromes Clinical Trial

— EWOG MDS 2006  

Official title:

Prospective Non-randomized Multi-center Study for Epidemiology and Characterization of Myelodysplastic Syndromes (MDS) and Juvenile Myelomonocytic Leucemia (JMML) in Childhood

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00662090
• Other study ID #: EWOG MDS 2006
• Status: Active, not recruiting
• Start date: January 2006
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Other known NCT identifiers

• NCT00898339

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 260
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 215 Months

Eligibility

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).

Related Conditions & MeSH terms

• Juvenile Myelomonocytic Leukemia
• Leukemia, Myelomonocytic, Juvenile
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Locations

Country	Name	City	State
Germany	University Hospital of Freiburg	Freiburg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the frequency of the different subtypes of MDS in childhood and adolescence by a standardized diagnostic approach		5 years
Primary	To evaluate the frequency of cytogenetic and molecular abnormalities		5 years
Secondary	To assess survival for children and adolescents with MDS and JMML		5 years
Secondary	To evaluate relapse rate, morbidity and mortality in children with MDS and JMML treated by HSCT		5 years

External Links

•   Homepage of the EWOG-MDS-Study Group