Clinical trial NCT06744712: Pharmacogenomic Testing in Pediatric Hematology/Oncology Patients
Official title: Pharmacogenomic Testing in Pediatric Hematology/Oncology Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Keywords: Pharmacogenomic
Anti-Cancer Therapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
name: OneOme, LLC
First posted: 2024-12-20
Enrollment: 130
Sex: ALL
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: This is a prospective, non-treatment, interventional single-arm study evaluating PGx results and modifications made to anticancer therapy and supportive medication administration based on PGx results in participants ≤ 26 years old with a newly diagnosed malignancy or bone marrow transplant candidate with non-malignant diagnosis who has not yet undergone myeloablative conditioning regimen.

Potential candidates will be presented with consent. Patients who agree will undergo the informed consent process, and participants who consent will be screened for eligibility. Those meeting eligibility criteria will be enrolled and undergo buccal swab collection. The buccal swab will be collected and sent for PGx testing at time of enrollment.

A copy of the test results in PDF (Portable Document Format) format and PGx consultation note will be uploaded to the participant's electronic medical record (EMR) and will be available to the participant via the MyAtrium Patient Portal and treating oncologist in the EMR. Results will also be reviewed by the pediatric oncology pharmacists. Apart from the availability and use of PGx test results to guide pharmacotherapy, participants will receive standard of care treatment as recommended by their primary oncologist.

During study participation, dose modifications made to anticancer therapy and supportive care medications based on PGx results will be collected every three months.

Participants are enrolled voluntarily after informed consent/assent and will not be reimbursed for study participation. Participants will receive PGx testing at no cost.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent and HIPAA authorization for release of personal health information, and assent when applicable, from the participant, parent or legal guardian.
2. Age ≤ 26 years at the time of consent.
3. 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.

Exclusion Criteria:

1. Anti-cancer therapy has already been initiated. Note: Enrollment after initiation of intrathecal chemotherapy will be allowed.
2. Previously received bone marrow transplant or planning to receive as part of initial upfront therapy for a malignant condition.
3. Prior history of tissue or organ transplant.

Primary outcomes:
measure: Gene-drug interaction
timeFrame: 3, 6, 9, 12 months after enrollment
measure: Genotype
timeFrame: Baseline
Secondary outcomes:
measure: Anticancer treatment modification based on PGx test result
timeFrame: 3, 6, 9, 12 months after enrollment
measure: Modification in supportive medication based on PGx test result
timeFrame: 3, 6, 9, 12 months after enrollment
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Levine Childrens Hospital Pediatric Cancer and Blood Disorders
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Erin Trovillion, MD
role: PRINCIPAL_INVESTIGATOR
References: