All MalignanciesNCT00730678
Pharmacogenetic Determinants Of Treatment Response In Children
An observational study of All Malignancies and Children Being Treated for Catastrophic Illness, run by St. Jude Children's Research Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- All Malignancies, Children Being Treated for Catastrophic Illness
- How many people
- 8,800 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 1998to Mar 2034
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients treated at St. Jude Children's Research Hospital are eligible to participate in this study.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Jun J. Yang, Ph. D., 888-226-4343, referralinfo@stjude.org
Jun J. Yang, Ph. D.
About this study
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.
Read the 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.
- Keywords
- Metabolism, Pharmacogenetic testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | All participants enrolled on this study will have blood drawn for genetic testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study start17 Aug 1998
- Primary completionDec 2033 (estimated)
- Study completionMar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All MalignanciesStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Jun J Yang, Ph. D., Principal investigator, St. Jude Children's Research HospitalKristine Crews, PharmD, MSCI, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730678
- Sponsor's protocol ID
- PGEN5
- Other IDs
- R37CA036401, P50GM115279, R01CA036401, R01GM118578, R35GM141947, R01CA264837, NCI-2021-09904
- Status last verified
- Apr 2026
- First submitted
- 6 Aug 2008
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No