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Screening for transient leukemia in children with Down syndrome.

Screening for transient myeloproliferative disorder in children with Down syndrome.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON19924
Enrollment
811
Registered
2009-02-11
Start date
2008-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transient myeloproliferative disorder in children with Down syndrome.

Interventions

Treatment will be advised when there is high MRD (above threshold) at week 8.

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. All children with Down syndrome; 2. Age < 4 weeks; 3. If blasts are present in pleural or pericardial effusion, or in a liverbiopsy (in absence of blasts in peripheral blood); 4. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Children in whom the diagnosis Down syndrome can not be confirmed; 2. Complications that make sampling unwanted or impossible.

Design outcomes

Primary

MeasureTime frame
1. To determine the population-based frequency of TMD; 2. To establish and investigate the relation of TMD and ML-DS; 3. To see if treatment of TMD can prevent TMD-associated mortality and the development of ML-DS in later life.

Secondary

MeasureTime frame
1. To detect new genetic factors related to the progression of TMD to ML-DS; 2. To investigate the presence of lymphoid pre-leukemic clones in neonatal blood samples of TMD; 3. To describe the hematological abnormalities and clinical characteristics in patients with and without TMD.

Contacts

Public ContactM. Blink

Dept of Paediatric Haematology/Oncology Erasmus MC- Sophia Children's Hospital POB 2060

m.blink@erasmusmc.nl+31 (0)10 7044640

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)