Pharmacogenomic Testing in Pediatric Hematology/Oncology Patients

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06744712
Status
Not Yet Recruiting

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Conditions

  • Pediatric Cancer

Eligibility Criteria

Sex
ALL
Age
N/A - 26 Years
Healthy Volunteers
Not accepted

Interventions

  • Pharmacogenomic Testing — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Aug 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Pharmacogenomic (PGx) Testing

Primary Outcome Measure

Gene-drug interaction [ Time Frame: 3, 6, 9, 12 months after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Levine Childrens Hospital Pediatric Cancer and Blood DisordersCharlotteNorth Carolina28203
Meg Lattanze
980-349-6887
Erin Trovillion, MD (PRINCIPAL_INVESTIGATOR)

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