Cancer, Gastrointestinal Cancer
Conditions
Brief summary
The purpose of this research is to evaluate the impact of a microarray PGx test on prescribing/dosing of drugs and cancer treatments in patients with cancer who are currently eligible for single-gene DPYD testing.
Detailed description
This is a prospective, non-randomized, Phase 2 study. The target population is adults ≥18 years of age who have received or will be receiving standard of care single-gene DPYD (dihydropyrimidine dehydrogenase) PGx testing to help guide dosing for their cancer treatment. Pharmacogenes that will be reported back to participants and providers from the microarray test are expected to take approximately one week and will be evaluated by the PGx team and uploaded to the participant's electronic medical record (EMR). Only clinically actionable results per CPIC and FDA guidelines will be included in the participant report. Participants will be followed on study for approximately 6 months to collect data on the number of drug prescriptions with known drug-gene interactions and potentially actionable results, BPAs fired, and actions taken due to BPAs.
Interventions
GENETICPharmacogenomic Testing with the "Global Diversity Array with Enhanced PGx"
Pharmacogenomic (PGx) microarray testing will test for certain pharmcogenes that can guide prescribing of certain cancer treatments and/or supportive care medications.
Sponsors
Wake Forest University Health Sciences
Atrium Health Levine Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent and HIPAA authorization for release of personal health information. * Age ≥ 18 years at the time of consent. * Eligible for standard of care single-gene DPYD testing (i.e., receiving or expected to receive a fluoropyrimidine-based chemotherapy regimen). The potential participant meets inclusion criteria if the standard of care single-gene DPYD test is planned or previously ordered. If previously ordered, consent must occur no later than 60 days from the date the DPYD results were available. * Willing to provide additional buccal swabs if residual DNA from previous DPYD testing is inadequate for microarray testing.
Exclusion criteria
• History of prior allogeneic hematopoietic cell transplantation or liver transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of potentially actionable results based on pharmacogenomic (PGx) test | Baseline | A potentially actionable result refers to any genotype or phenotype that is associated with specific drug-gene interactions from the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines or the FDA's Table of Pharmacogenetic Associations. The number of potentially actionable results is a count variable that represents the total occurrences of such genotypes or phenotypes identified in a participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The presence of at least one drug-gene interaction | Baseline, at 3 months and at 6 months after receiving the microarray profiling results | Drug-gene interactions is defined as an interaction between the medication(s) taken by the subject and the genetic variant(s) the subject possesses based on the PGx test. The presence or absence of such interactions is assessed using the guidelines provided by the Clinical Pharmacogenetics Implementation Consortium (CPIC) or the FDA's Table of Pharmacogenetic Associations. The presence of at least one drug-gene interaction is a binary variable (yes/no). |
| The presence of at least one PGx best practice advisory (BPA) alert | within 6 months of receiving the microarray profiling results | BPA alert is fired within the Epic electronic health record (EHR) system for the participant when there is presence of a drug-gene interaction at the time of medication order entry. The presence of at least one PGx best practice advisory (BPA) alert for each participant is a binary variable (yes, no). |
| Percentage of prescriptions that trigger PGx best practice advisory (BPA) alerts | within 6 months of receiving the microarray profiling results | Percentage of prescriptions that trigger PGx best practice advisory (BPA) alert among all prescriptions for each participant |
| Taking actions from PGx best practice advisory alerts | within 6 months of receiving the microarray profiling results | Taking actions after receiving PGx best practice advisory alerts includes remove or keep drug, order or do not order an e-consult, patient previously tolerated/responded treatment, not appropriate, or other. Taking actions is a binary variable (yes, no). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJai Patel, PharmD
Atrium Health Levine Cancer
Outcome results
None listed