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Functional Pharmacogenomics of Childhood Acute Lymphoblastic Leukemia in Taiwan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00526084
Recruitment Status : Unknown
Verified December 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 6, 2007
Last Update Posted : September 6, 2007
Information provided by:
National Taiwan University Hospital

Brief Summary:

Emerging results suggest that a cure rate of nearly 90 percent will be attained in the near future. The advance was attributed to stringent application of prognostic factors for risk factor-directed therapy. Early response to treatment has greater prognostic strength than does any other biologic or clinical feature tested to dates. The measurement of minimal residual disease(MRD) affords a level of sensitivity and specificity that cannot be attained through traditional microscopic morphologic assessments. In Taiwan, detection for the most recurrent fusion genes and the MRD were not commonly available, the TPOG(Taiwan Pediatric Oncology Group) used clinical features, immunophenotypes, and cytogenetics to do risk group classifications and protocol assignment. A successful rate of 60-70% has been reached. In order to improve the cure rate of ALL in Taiwan, this project aims at establishing the methods for better risk classifications and establishing MRD detection for risk-directed therapy for childhood ALL in Taiwan.Intrinsic and acquired resistances to multiple anticancer agents represent major obstacles and accounts for 10-20% of treatment failure in the developed countries nowadays. Recent progress using DNA microarray identified differential expression level of the genes known to implicate in cell cycle control, DNA repair and apoptosis in different subsets of ALL patients, which were found to be related to drug response. Genetic polymorphisms in the genes of drug-metabolizing enzymes, drug transporters or drug targets, can influence the efficacy or toxicity of antileukemic agents. Specific genotype might be important in determining the pharmacokinetic effects of one population or disease subtype from that in others. Recently, the expression profiles of relatively few microRNAs (miRNAs) (~200 genes), was noted to accurately classify human cancers. These informations hinted that expression of the genes in the leukemic cells might serve as additional risk factors for treatment stratification.

Specific aims and goals:

  1. to establish better risk factors classification and use MRD to monitor early response to treatment.
  2. to establish the expression profiles of 12 genes associated with drug resistance
  3. to unravel the pharmacogenetic background of pediatric ALL in Taiwan, so that will help refine the therapy dose, achieve a better drug effect and avoid acute or chronic toxicity.
  4. microRNA expression profiles in childhood ALL in Taiwan

Condition or disease
Leukemia, Lymphocytic, Acute

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Defined Population
Time Perspective: Other
Official Title: Functional Pharmacogenomics of Childhood Acute Lymphoblastic Leukemia in Taiwan
Study Start Date : March 2007
Estimated Study Completion Date : December 2009

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ALL, healthy

Information from the National Library of Medicine

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 identifier (NCT number): NCT00526084

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Contact: Yung-Li Yang, MD 886-968663341 ext 2394
Contact: Dong-Tsamn Lin, MD 886-2-23123456 ext 5399

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Chung-Yi Hu Recruiting
Taipei, Taiwan, 100
Contact: Chung-Yi Hu, PhD    886-2-23123456 ext 6914   
Contact: Dong-Tsam Lin, MD    886-2-23123456 ext 5399   
Principal Investigator: Chung-Yi Hu, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Chung-Yi Hu, PhD Department of Clinical Laboratory Sciences and Medical Biotechonology
Principal Investigator: Shu-Wha Lin, PhD Department of Clinical Laboratory Sciences and Medical Biotechonology
Principal Investigator: Lan-Yang Chang, PhD Department of Clinical Laboratory Sciences and Medical Biotechonology
Layout table for additonal information Identifier: NCT00526084    
Other Study ID Numbers: 9561709144
First Posted: September 6, 2007    Key Record Dates
Last Update Posted: September 6, 2007
Last Verified: December 2005
Keywords provided by National Taiwan University Hospital:
Healthy subjects
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases