We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : 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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
All Malignancies Children Being Treated for Catastrophic Illness

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 8800 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
All Participants
All participants enrolled on this study will have blood drawn for genetic testing.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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
DNA or RNA for genetic testing will typically be obtained simultaneously with blood that is drawn for clinical reasons.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients treated at St. Jude Children's Research Hospital are eligible to participate in this study.
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Clinton F. Stewart, Pharm.D. 1-866-278-5833 referralinfo@stjude.org

Locations
Layout table for location information
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Clinton F. Stewart, Pharm.D.    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Clinton F. Stewart, Pharm.D.         
Principal Investigator: Jun J. Yang, Ph.D.         
Sponsors and Collaborators
St. Jude Children's Research Hospital
National Cancer Institute (NCI)
National Institute of General Medical Sciences (NIGMS)
Investigators
Layout table for investigator information
Principal Investigator: Clinton F. Stewart, Pharm.D. St. Jude Children's Research Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: 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 )
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Jude Children's Research Hospital:
Metabolism
Pharmacogenetic testing
Additional relevant MeSH terms:
Layout table for MeSH terms
Catastrophic Illness
Disease Attributes
Pathologic Processes