Functional Pharmacogenomics of Childhood Acute Lymphoblastic Leukemia in Taiwan

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00526084
First received: September 4, 2007
Last updated: September 5, 2007
Last verified: December 2005
  Purpose

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
Leukemia, Lymphocytic, Acute

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Functional Pharmacogenomics of Childhood Acute Lymphoblastic Leukemia in Taiwan

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 500
Study Start Date: March 2007
Estimated Study Completion Date: December 2009
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ALL, healthy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526084

Contacts
Contact: Yung-Li Yang, MD 886-968663341 ext 2394 yangyl92@ntu.edu.tw
Contact: Dong-Tsamn Lin, MD 886-2-23123456 ext 5399 dtlin@ntuh.gov.tw

Locations
Taiwan
Chung-Yi Hu Recruiting
Taipei, Taiwan, 100
Contact: Chung-Yi Hu, PhD    886-2-23123456 ext 6914    jcyhu@ntu.edu.tw   
Contact: Dong-Tsam Lin, MD    886-2-23123456 ext 5399    dtlin@ntuh.gov.tw   
Principal Investigator: Chung-Yi Hu, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00526084     History of Changes
Other Study ID Numbers: 9561709144
Study First Received: September 4, 2007
Last Updated: September 5, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
ALL
Healthy subjects

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014