Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia
|ClinicalTrials.gov Identifier: NCT01556386|
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : July 14, 2014
|Condition or disease|
|Acute Lymphoblastic Leukemia|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia|
|Study Start Date :||June 2006|
|Primary Completion Date :||March 2012|
|Study Completion Date :||May 2012|
|Pharmacogenetic analysis, ALL|
- To find out distribution of genetic polymorphisms genes related to the pharmacodynamics of the ALL therapy [ Time Frame: up to 3 years from diagnosis ]
- The distribution of each genetic polymorphism is descriped.
- The differences in genetic polymorphism between risk groups (high vs. standard) are analyzed using the chi-square test or Fisher's exact test.
- To see the ethnic difference of genetic polymorphisms related to the chemotehrapeutic drugs of ALL [ Time Frame: whenever after diagnosis and genetic analysis (no time frame needed) ]• The differences in genetic polymorphism between other populations (Korean vs. Western or Japanese) are analyzed using the chi-square test or Fisher's exact test.
- To find out relation of genetic polymorphisms and clinical outcome (relapse or survival) [ Time Frame: up to 3 years from diagnosis ]- Event-free and overall survival are estimated using Kaplan-Meier analysis, and the survival differences according to different genetic polymorphisms and prognostic variables are analyzed by log-rank test.
- To find out risk factors of relapse and death [ Time Frame: up to 3 years from diagnosis ]- Multivariate analysis is conducted with Cox proportional hazards regression model to analyze predictive factors. For the multivariate analysis, all significant univariate variables are entered in a stepwise, forward-selection protocol.
Biospecimen Retention: Samples With DNA
Candidate genes exhibit polymorphisms and encodes proteins that are involved in the pharmacokinetics and pharmacodynamics of antileukemic agents
- Priority was given to polymorphism that were demonstrated to be associated with phenotypes in both clinical and preclinical studies.
- Candidate genes : CYP3A4*1B, CYPA5*3, GSTM1 deletion, GSTP1 313, GSTT1 deletion, MDR exon 21, MDR exon 26, MTHFR 677, MTHFR 1298, NR3C1 1088, RFC 80, TPMT-1 238, TPMT-1 460, TPMT-1 719, VDR intron 8, VDR FokI, ITPA
- Blood sample at complete remission→DNA extraction
- Total-Plex (multiplex) PCR amplification
- Luminex system analysis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556386
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Chongno-gu, Korea, Republic of|
|Principal Investigator:||Hyoung Jin Kang, MD. PhD.||Seoul National University Hospital|