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Pharmacogenetic Determinants Of Treatment Response In Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by St. Jude Children's Research Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00730678
First received: August 6, 2008
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
All Malignancies
Children Being Treated for Catastrophic Illness
Procedure: Blood draw

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pharmacogenetic Determinants Of Treatment Response In Children

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 8800
Study Start Date: July 1998
Estimated Study Completion Date: March 2034
Estimated Primary Completion Date: December 2033 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
All Participants
All participants enrolled on this study will have blood drawn for genetic testing.
Procedure: Blood draw
DNA or RNA will typically be obtained simultaneously with blood that is drawn for clinical reasons.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  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: NCT00730678

Contacts
Contact: William E Evans, Pharm.D 1-866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: William E Evans, Pharm.D    866-278-5833    info@stjude.org   
Principal Investigator: William E Evans, Pharm.D         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: William E Evans, Pharm.D St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00730678     History of Changes
Other Study ID Numbers: PGEN5, R37CA036401
Study First Received: August 6, 2008
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Metabolism
Pharmacogenetic testing

Additional relevant MeSH terms:
Catastrophic Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014