S9031-S9126-S9333-S9500-A, Studying Bone Marrow and Blood Samples From Patients With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00899171|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : March 6, 2015
RATIONALE: Studying samples of bone marrow and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at bone marrow and blood samples from patients with acute myeloid leukemia.
|Condition or disease||Intervention/treatment|
|Leukemia||Genetic: DNA analysis Genetic: DNA methylation analysis Genetic: RNA analysis Genetic: gene expression analysis Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis|
- To determine whether the expression of previously identified acute myeloid leukemia (AML)-specific and age-associated genes have prognostic significance in adult patients with AML.
- To examine, preliminarily, if AML-specific and age-associated expression changes occur in the most primitive hematopoietic leukemia blasts (i.e., CD34+/38-).
- To examine, preliminarily, whether methylation or histone modification of the IRF8 CPG island/promoter region is correlated with IRF8 gene expression in AML.
OUTLINE: This is a multicenter study.
Previously collected specimens of RNA from pre-treatment marrow or peripheral blood are obtained from a repository of SWOG clinical trials (SWOG-S9031, SWOG-9126, SWOG-9333, and SWOG-9500). Samples are analyzed for absolute expression levels of 23 selected genes and relative expression levels of splice variants via quantitative RT/PCR and GeneScan assays and linked to clinical and outcome data from the main SWOG database. Samples from a subset of patients are analyzed to confirm aberrant expression of acute myeloid leukemia-specific and age-associated genes in highly enriched population of leukemic blasts (CD34+/CD38- and CD34+/CD38+). DNA samples are also analyzed for correlation of IRF8 gene expression with methylation or histone modification of the IRF8 CPG island/promoter region.
|Study Type :||Observational|
|Actual Enrollment :||251 participants|
|Official Title:||S9031-S9126-S9333-S9500-A, Examination of the Prognostic Significance of AML-Specific and Age-Associated Genes in AML Patients|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
- Prognostic significance for complete response, overall survival, and relapse-free survival of total and relative expression levels (variant/wild type ratios) for each gene [ Time Frame: immediate ]
- Role of acute myeloid leukemia (AML)-specific and age-associated genes in the biology and prognosis of AML [ Time Frame: immediate ]
- Role of methylation and histone modification in IRF8 gene expression [ Time Frame: immediate ]
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): NCT00899171
|Study Chair:||Derek L. Stirewalt, MD||Fred Hutchinson Cancer Research Center|
|Study Chair:||Cheryl L. Willman, MD||University of New Mexico Cancer Center|