Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia
1 other identifier
observational
200
1 country
1
Brief Summary
This study is to find out distribution of genetic polymorphisms and genes related to the chemotherapeutic drugs of ALL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 8, 2012
CompletedFirst Posted
Study publicly available on registry
March 16, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJuly 14, 2014
December 1, 2013
5.8 years
March 8, 2012
July 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To find out distribution of genetic polymorphisms genes related to the pharmacodynamics of the ALL therapy
* 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.
up to 3 years from diagnosis
Secondary Outcomes (3)
To see the ethnic difference of genetic polymorphisms related to the chemotehrapeutic drugs of ALL
whenever after diagnosis and genetic analysis (no time frame needed)
To find out relation of genetic polymorphisms and clinical outcome (relapse or survival)
up to 3 years from diagnosis
To find out risk factors of relapse and death
up to 3 years from diagnosis
Study Arms (1)
Pharmacogenetic analysis, ALL
Eligibility Criteria
All the patients with acute lymphoblastic leukemia who was diagnosed and treated in SNUCH.
You may qualify if:
- Clinical diagnosis of acute lymphoblastic leukemia
- In case of informed consent and assent
You may not qualify if:
- Paients or parents refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Chongno-gu, South Korea
Biospecimen
1. 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 2. Blood sample at complete remission→DNA extraction 3. Total-Plex (multiplex) PCR amplification 4. Luminex system analysis
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyoung Jin Kang, MD. PhD.
Seoul National University Hospital
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD. Ph D., Professor
Study Record Dates
First Submitted
March 8, 2012
First Posted
March 16, 2012
Study Start
June 1, 2006
Primary Completion
March 1, 2012
Study Completion
May 1, 2012
Last Updated
July 14, 2014
Record last verified: 2013-12