Pharmacogenetic Determinants Of Treatment Response In Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

8800 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-08-17

Study Completion Date

2034-03-31

Brief Summary

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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. To investigate the nature of heritability and the genetic basis of pharmacogenetic traits by studying family members of individuals with specific genotypes.

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Detailed Description

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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.

Conditions

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All Malignancies Children Being Treated for Catastrophic Illness

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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All Participants

All participants enrolled on this study will have blood drawn for genetic testing.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Any patients under evaluation/treatment at St. Jude Children's Research Hospital (SJCRH)
* Parents or family members of St. Jude patients
* Non patient volunteers
* All study subjects must provide informed consent for participation
* Assent/Consent of the patient (parent) must be provided prior to attempts made by investigators to enroll a family member of a SJCRH patient

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun J Yang, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Kristine Crews, PharmD, MSCI

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

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St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jun J. Yang, Ph. D.

Role: CONTACT

[email protected]

1-866-278-5833

Facility Contacts

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Jun J. Yang, Ph. D.

Role: primary

[email protected]

866-278-5833