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Pharmacogenetic Determinants Of Treatment Response In Children

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ClinicalTrials.gov Identifier: NCT00730678
Recruitment Status : Recruiting
First Posted : August 8, 2008
Last Update Posted : March 31, 2022
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date August 6, 2008
First Posted Date August 8, 2008
Last Update Posted Date March 31, 2022
Actual Study Start Date August 17, 1998
Estimated Primary Completion Date December 2033   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2012)
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 ]
Original Primary Outcome Measures
 (submitted: August 7, 2008)
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: 10 years ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pharmacogenetic Determinants Of Treatment Response In Children
Official Title Pharmacogenetic Determinants Of Treatment Response In Children
Brief Summary 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.
Detailed Description

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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA or RNA for genetic testing will typically be obtained simultaneously with blood that is drawn for clinical reasons.
Sampling Method Non-Probability Sample
Study Population All patients treated at St. Jude Children's Research Hospital are eligible to participate in this study.
Condition
  • All Malignancies
  • Children Being Treated for Catastrophic Illness
Intervention Not Provided
Study Groups/Cohorts All Participants
All participants enrolled on this study will have blood drawn for genetic testing.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 18, 2013)
8800
Original Estimated Enrollment
 (submitted: August 7, 2008)
2000
Estimated Study Completion Date March 2034
Estimated Primary Completion Date December 2033   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Clinton F. Stewart, Pharm.D. 1-866-278-5833 referralinfo@stjude.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00730678
Other Study ID Numbers PGEN5
R37CA036401 ( U.S. NIH Grant/Contract )
P50GM115279 ( U.S. NIH Grant/Contract )
R01CA036401 ( U.S. NIH Grant/Contract )
R01GM118578 ( U.S. NIH Grant/Contract )
R35GM141947 ( U.S. NIH Grant/Contract )
R01CA264837 ( U.S. NIH Grant/Contract )
NCI-2021-09904 ( Registry Identifier: NCI Clinical Trial Registration Program )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party St. Jude Children's Research Hospital
Study Sponsor St. Jude Children's Research Hospital
Collaborators
  • National Cancer Institute (NCI)
  • National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Clinton F. Stewart, Pharm.D. St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date March 2022