- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01556386
Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia
July 11, 2014 updated by: Hyo Seop Ahn, Seoul National University Hospital
This study is to find out distribution of genetic polymorphisms and genes related to the chemotherapeutic drugs of ALL.
Study Overview
Status
Completed
Conditions
Detailed Description
Cure rate of pediatric ALL dramatically improved over 80%.
Resistance to drug and hematologic relapse are remaining problem in ALL treatment.
One of the explanations of drug resistance and toxicities is the pharmacogenetic effect.
Germline polymorphisms in genes that code for proteins involved in the pharmacokinetics and pharmacodynamics of antileukemic agents are various, and inter-patient variability is the main factor for pharmacogenetic difference.
Since multiple chemotherapeutic agents are involved in treating ALL, many genes related to the metabolic pathways of those drugs have an effect on the pharmacokinetics of patients with ALL.
In Korea, pharmacogenetic study including multiple genetic loci for pediatric ALL has not been reported.In this study, the distribution of genetic polymorphisms and genes related to antileukemic drugs were analyzed, and their relations to the outcome of treatment and relapse rates were assessed.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Chongno-gu
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Seoul, Chongno-gu, Korea, Republic of
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All the patients with acute lymphoblastic leukemia who was diagnosed and treated in SNUCH.
Description
Inclusion Criteria:
- Clinical diagnosis of acute lymphoblastic leukemia
- In case of informed consent and assent
Exclusion Criteria:
- Paients or parents refusal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Pharmacogenetic analysis, ALL
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To find out distribution of genetic polymorphisms genes related to the pharmacodynamics of the ALL therapy
Time Frame: up to 3 years from diagnosis
|
|
up to 3 years from diagnosis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
whenever after diagnosis and genetic analysis (no time frame needed)
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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.
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up to 3 years from diagnosis
|
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.
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up to 3 years from diagnosis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hyoung Jin Kang, MD. PhD., Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
March 8, 2012
First Submitted That Met QC Criteria
March 15, 2012
First Posted (Estimate)
March 16, 2012
Study Record Updates
Last Update Posted (Estimate)
July 14, 2014
Last Update Submitted That Met QC Criteria
July 11, 2014
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNUCH-1202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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