Pharmacogenetic Determinants Of Treatment Response In Children
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00730678|
Recruitment Status : Recruiting
First Posted : August 8, 2008
Last Update Posted : September 11, 2019
|Condition or disease|
|All Malignancies Children Being Treated for Catastrophic Illness|
Pharmacogenetics is that discipline devoted to elucidating the genetic determinants of drug response. Particularly in the area of drug metabolism, many genes exhibit genetic polymorphism; that is, a stable percentage of the population (which generally differs by ethnic group) is deficient in the functional expression of the enzyme involved, and the deficiency is typically inherited as an autosomal recessive trait. With currently known polymorphisms in drug metabolism, the percentage of homozygous deficient individuals ranges from 0.3% to as many as 90% of the population, depending on the enzyme and the ethnic group.
Our prior studies have revealed multigenic pharmacogenetic models that are significantly predictive of various drug response phenotypes (e.g., drug resistance, drug clearance, drug toxicity, disease response) in children with ALL. The large number of candidate loci and the relatively small number of patients illustrate the fact that larger sample sizes are required to definitively establish these polygenic models. The fact that there were significant race/genotype interactions, such that predictions differed in whites vs blacks, highlights the need for adequate numbers of patients within racial and ethnic groups to allow differential analysis of genotypic predictors after adjusting for confounding demographic factors in pharmacogenetic studies via stratified design and analyses.
|Study Type :||Observational|
|Estimated Enrollment :||8800 participants|
|Official Title:||Pharmacogenetic Determinants Of Treatment Response In Children|
|Actual Study Start Date :||August 17, 1998|
|Estimated Primary Completion Date :||December 2033|
|Estimated Study Completion Date :||March 2034|
All participants enrolled on this study will have blood drawn for genetic testing.
- To investigate whether genetic polymorphisms in genes encoding proteins involved in the metabolism or effects of drugs or environmental agents influence the disposition or effects of these xenobiotic substrates. [ Time Frame: 28 years ]
Biospecimen Retention: Samples With DNA
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): NCT00730678
|Contact: William E Evans, Pharm.Demail@example.com|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: William E Evans, Pharm.D 866-278-5833 firstname.lastname@example.org|
|Principal Investigator: William E Evans, Pharm.D|
|Principal Investigator:||William E Evans, Pharm.D||St. Jude Children's Research Hospital|