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
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Condition or disease |
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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 |
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 |
Group/Cohort |
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All Participants
All participants enrolled on this study will have blood drawn for genetic testing.
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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. [ Time Frame: 28 years ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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:

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: Clinton F. Stewart, Pharm.D. | 1-866-278-5833 | referralinfo@stjude.org |
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. |
Principal Investigator: | Clinton F. Stewart, Pharm.D. | St. Jude Children's Research Hospital |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Metabolism Pharmacogenetic testing |
Catastrophic Illness Disease Attributes Pathologic Processes |