Pharmacogenetic Determinants Of Treatment Response In Children

All Malignancies Clinical Trial

Official title:

Pharmacogenetic Determinants Of Treatment Response In Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00730678
• Other study ID #: PGEN5
• Secondary ID: R37CA036401P50GM
• Status: Recruiting
• Start date: August 17, 1998
• Est. completion date: March 2034

Study information

• Verified date: January 2024
• Source: St. Jude Children's Research Hospital
• Contact: Clinton F. Stewart, Pharm.D.
• Phone: 1-866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8800
• Est. completion date: March 2034
• Est. primary completion date: December 2033
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• All Malignancies
• Children Being Treated for Catastrophic Illness

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Cancer Institute (NCI), National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		28 years

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital