Genome Wide SNP Array-based Approach to Detect Micro-cytogenetic Lesions and KIT Mutation to Improve Treatment Outcomes in Patients With Core-binding Factor Positive Acute Myeloid Leukemia
|ClinicalTrials.gov Identifier: NCT01066286|
Recruitment Status : Unknown
Verified February 2010 by Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : February 10, 2010
Last Update Posted : February 10, 2010
Core binding factor (CBF) positive acute myeloid leukemia (AML) consist of 15% of patients in overall AML, expected to harbor a favorable prognosis. However, around a half of cases relapses. Accordingly, more sophisticated classification in CBF positive AMLs is essential to achieve further improvement in the treatment outcome. The current study is designed to evaluate CBF positive AML patients with genome-wide SNP array and KIT mutation study in CBF positive AML patients diagnosed at the Samsung Medical Center and Hwasun Chonnam National University Hospital, Korea between 1994 and 2008.
- Construction of the CBF positive AML patient cohort: clinical database establishment (including treatment outcomes and prognosis) and extraction/storage of tumor cell DNAs from marrow samples, then processing of Affymetrix SNP array 6.0.
- Construction of prognostic predictive model using pharmacogenomics with the results of genotypes and copy number variations (CNVs).
- Detection of hidden microscopic cytogenetic lesions with SNP array technique, and correlation with clinical outcomes in CBF positive AML.
- Detection of KIT, FLT3/ITD, and NPM1 gene mutation and its correlation with clinical outcomes in CBF positive AML.
The current study attempts to analyze genetic data of core binding factor (CBF) positive acute myeloid leukemia (AML) using genome wide SNP array technique with tumor DNAs collected at the time of diagnosis.
- To detect microcytogenetic lesions and will analyze its prognostic significance
- To analyze genome-wide genotypes and copy number variations (CNVs) using pharmacogenetic approach and will construct a prognostic predictive model
- To detect KIT, FLT3/ITD and NPM1 mutation and evaluate its prognostic significance. The present study will establish individualized therapy for CBF positive AML, will provide a basis for molecular marker guided clinical trial in CBF positive AML.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Genome Wide SNP Array-based Approach to Detect Micro-cytogenetic Lesions and KIT Mutation to Improve Treatment Outcomes in Patients With Core-binding Factor Positive Acute Myeloid Leukemia|
|Study Start Date :||February 2010|
core binding factor positive
core binding factor positive acute myeloid leukemia
- response rate [ Time Frame: within 1 month after enrollment ]
- overall survival and progression-free survival [ Time Frame: within 1 month after enrollment ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066286
|Contact: Dong Hwan Kim, M.D.,Ph.D.||+email@example.com|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Dong Hwan Kim, M.D., Ph. D. +82-2-3410-1768 firstname.lastname@example.org|
|Principal Investigator: Dong Hwan Kim, M.D.,Ph.D.|
|Principal Investigator:||Dong Hwan Kim, M.D.,Ph.D.||Division of Hematology and Oncology/Samsung Medical Center|