DNA Analysis of Bone Marrow and Blood Samples From Young Patients With Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at DNA in bone marrow and blood samples from young patients with acute myeloid leukemia or acute lymphoblastic leukemia.
Genetic: Southern blotting
Genetic: chromosomal translocation analysis
Genetic: cytogenetic analysis
Genetic: gene rearrangement analysis
Genetic: mutation analysis
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Molecular Epidemiology of de Novo and Treatment Related 11q23 Leukemia in the Young|
- Clinical, morphologic, immunologic, cytogenetic, and molecular characteristics of acute lymphoblastic leukemia and de novo and secondary acute myeloid leukemia (AML) [ Designated as safety issue: No ]
- Comparison of secondary AML vs de novo AML at the level of Southern blot, breakpoint sequence, and DNA topoisomerase II cleavage sites [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
marrow, blood, pheresis bag
|Study Start Date:||January 1997|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
Completion of Telephone Study Entry Form, Additional On Study Form, and Specimen Transmittal Form.
|Genetic: Southern blotting Genetic: chromosomal translocation analysis Genetic: cytogenetic analysis Genetic: gene rearrangement analysis Genetic: mutation analysis|
- Characterize the clinical, morphologic, immunologic, cytogenetic, and molecular heterogeneity of acute lymphoblastic leukemia or acute myeloid leukemia (AML) in infants and monoblastic variants of AML in young patients.
- Characterize the clinical, morphologic, immunologic, cytogenetic, and molecular heterogeneity of secondary AML in young patients.
- Compare secondary AML vs de novo AML at the level of Southern blot, breakpoint sequence, and DNA topoisomerase II cleavage sites.
OUTLINE: This is a multicenter study.
Bone marrow or blood are collected and analyzed by Southern blot for chromosome 11q23 breakpoints and translocations. Samples from patients with secondary acute myeloid leukemia are also examined for MLL gene rearrangements.
PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899652
|Study Chair:||Beverly J. Lange, MD||Children's Hospital of Philadelphia|
|Investigator:||Carolyn A. Felix, MD||Children's Hospital of Philadelphia|