Status:
COMPLETED
Study of Blood Samples From Newborns With Down Syndrome
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Myeloid Proliferations Associated With Down Syndrome
Eligibility:
All Genders
Up to 90 years
Brief Summary
This research study is looking at blood samples from newborns with Down syndrome. Studying the genes expressed in samples of blood from patients with Down syndrome may help doctors identify biomarkers...
Detailed Description
PRIMARY OBJECTIVES: I. To further our biological understanding of the natural history of transient myeloproliferative disorder (TMD) and its relationship to subsequent leukemia by facilitating the de...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Diagnosis of transient myeloproliferative disorder (TMD) at \< 90 days of age and meeting 1 of the following criteria:
- A diagnosis of Down syndrome or Down syndrome mosaicism AND non-erythroid and non-lymphoid blasts (any amount) in the peripheral blood verified with a second sample
- Patients with typical physical characteristics of Down syndrome are allowed before cytogenetic or FISH confirmation of the diagnosis
- Trisomy 21-positive leukemic blasts documented by biopsy of any organ (including \> 5% non-erythroid/non-lymphoid blasts documented by bone marrow aspirate or biopsy)
- Infants with isolated trisomy 21 positivity identified only in the leukemic blasts are allowed
- Institutional immunophenotype characterization is required for study enrollment
Exclusion
Key Trial Info
Start Date :
February 23 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00959283
Start Date
February 23 2009
End Date
September 30 2023
Last Update
October 3 2023
Active Locations (189)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
3
USA Health Strada Patient Care Center
Mobile, Alabama, United States, 36604
4
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508