Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia
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|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|
|Actual Primary Completion Date :||March 2012|
|Actual 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
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): 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|