Genome-wide Pharmacogenetic Candidate Gene Single Nucleotide Polymorphism (SNP) Array-based Approach to Predict Chemoresponse and Survival in Patients With Acute Myeloid Leukemia With Normal Karyotype
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|ClinicalTrials.gov Identifier: NCT01066338|
Recruitment Status : Unknown
Verified February 2010 by Samsung Medical Center.
Recruitment status was: Recruiting
First Posted : February 10, 2010
Last Update Posted : February 19, 2010
The most reliable prognostic marker of acute myeloid leukemia(AML) is cytogenetics by karyotyping. According to cytogenetic results, the patients with AML are classified as better, intermediate and poor prognosis groups. The normal karyotype AML was reported in about 50% of all AML and classified as intermediate risk group. However, the patients with normal karyotype AML showed various prognosis. Therefore, the further studies about subgroup analysis of normal karyotype AML are needed. Recently, the understandings of human genome polypmorphism using SNP array have been accumulated. However, the advanced researches for clinical application are not enough.
The study design is a retrospective and single-center study. The patients with normal karyotyping AML who were diagnosed from 1994 to 2008 at Samsung Medical Center (South Korea) will be enrolled. The stored bone marrow samples of enrolled patients are used for genome wide scanning by SNP array.
The purpose of present study is to develop predictive pharmacogenemic biomarkers model associated wit clinical outcomes including efficacy and toxicity in patients with AML with normal karyotype treated with chemotherapy using pharmacogenetic SNP array. And secondly, to develop enrichment clinical trial based on predictive pharmacogenomic model.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Genome-wide Pharmacogenetic Candidate Gene SNP Array-based Approach to Predict Chemoresponse and Survival in Patients With Acute Myeloid Leukemia With Normal Karyotype|
|Study Start Date :||February 2010|
The patients were diagnosed as acute myeloid leukemia with normal karyotype.
- overall response rate [ Time Frame: within 1 month after enrollment ]
- overall survival time [ Time Frame: within 1 month after enrollment ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066338
|Contact: Dong Hwan Kim, M.D.,Ph.D.||+firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Dong Hwan Kim, M.D.,Ph.D.||Division of Hematology and Oncology/Samsung Medical Center|