DNA Analysis of Bone Marrow and Blood Samples From Young Patients With Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00899652|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : April 26, 2017
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.
|Condition or disease||Intervention/treatment|
|Leukemia||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.
|Study Type :||Observational|
|Actual Enrollment :||149 participants|
|Official Title:||The Molecular Epidemiology of de Novo and Treatment Related 11q23 Leukemia in the Young|
|Study Start Date :||January 1997|
|Actual Primary Completion Date :||September 2005|
|Actual Study Completion Date :||September 2006|
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
- Clinical, morphologic, immunologic, cytogenetic, and molecular characteristics of acute lymphoblastic leukemia and de novo and secondary acute myeloid leukemia (AML)
- Comparison of secondary AML vs de novo AML at the level of Southern blot, breakpoint sequence, and DNA topoisomerase II cleavage sites
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899652
|Study Chair:||Beverly J. Lange, MD||Children's Hospital of Philadelphia|
|OverallOfficial:||Carolyn A. Felix, MD||Children's Hospital of Philadelphia|