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Pharmacogenomic Testing in Pediatric Hematology/Oncology Patients

ConditionPediatric Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 26
SponsorWake Forest University Health Sciences

About this trial

Pharmacogenomic (PGx) testing involves analyzing variants of genes associated with drug metabolism, transport and medication targets. PGx testing uses an individual's genetic factors, such as single nucleotide polymorphisms (SNPs), to personalize therapy or dose a selection of medications. PGx testing has traditionally been used to test single genes, but there are now platforms allowing a panel of genes to be tested at once. To date there has not been a comprehensive screening of pediatric oncology patients to determine the prevalence of genetic variants that may affect anticancer therapy and supportive care medications. This study would allow us to summarize the frequency of clinically relevant gene-drug interactions and actionable genetic polymorphisms in pediatric oncology patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent and HIPAA authorization for release of personal health information, and assent when applicable, from the participant, parent or legal guardian.

Age ≤ 26 years at the time of consent.

Newly diagnosed with a malignancy and planning to undergo anti-cancer therapy; or bone marrow transplant candidate with a non-malignant diagnosis who has not yet undergone myeloablative conditioning regimen.

Disqualifiers

Anti-cancer therapy has already been initiated. Note: Enrollment after initiation of intrathecal chemotherapy will be allowed.

Previously received bone marrow transplant or planning to receive as part of initial upfront therapy for a malignant condition.

Prior history of tissue or organ transplant.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pharmacogenomic Testing

    Other intervention

    Pharmacogenomic testing will be completed by the vendor. The vendor is certified under CLIA-88 and accredited by the College of American Pathologists as qualified to perform high-complexity testing. Genomic DNA extracted from the swab will be analyzed by PCR using Thermo Fisher TaqMan® and/or LGC Biosearch BHQ® probe-based methods to interrogate the variant locations listed in (See Appendix II). Twenty-seven genes are evaluated and reported.

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: Pharmacogenomic (PGx) TestingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Gene-drug interaction

A gene-drug interaction occurs when an individual carrying a variant form of a gene is administered a drug that serves as a substrate for the enzyme or transporter encoded by that gene. Clinically relevant gene-drug interactions are defined in the CPIC (Clinical Pharmacogenetics Implementation Consortium) guidelines or the FDA Table of Pharmacogenomic Associations. Gene-drug interaction is a binary variable (interaction present or interaction absent). Each clinically relevant gene-drug interaction from the pharmacogenomic testing will be reported.

Time frame
3, 6, 9, 12 months after enrollment
2

Genotype

Genes involved in toxicity and efficacy of pediatric anticancer therapy and supportive care medications, as listed in CPIC or FDA Table of Pharmacogenomic Association guidelines, are tested for genetic polymorphisms using the OneOme RightMed Comprehensive Test. Each gene's genotype is classified as a binary variable (actionable or not actionable).

Time frame
Baseline

Secondary outcomes

1

Anticancer treatment modification based on PGx test result

Anticancer treatment modification includes modifications in medication, dosage, or treatment frequency. Anti-cancer therapy treatment modification is a binary variable (yes or no), where 'yes' indicates that at least one type of modification occurred.

Time frame
3, 6, 9, 12 months after enrollment
2

Modification in supportive medication based on PGx test result

Modification in supportive medication includes modifications in medication, dosage, treatment frequency, or adding new medication. Modification in supportive medication is a binary variable (yes or no), with 'yes' indicates at least one type of modification occurred.

Time frame
3, 6, 9, 12 months after enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Atrium Health Levine Cancer Institute

Collaborator

OneOme, LLC

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: