Evaluating Microarray Pharmacogenetic Testing in Cancer Patients
Evaluating the Use of Microarray Pharmacogenetic Testing in Patients With Cancer
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2024
CompletedFirst Posted
Study publicly available on registry
July 5, 2024
CompletedStudy Start
First participant enrolled
July 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
February 2, 2026
January 1, 2026
1.4 years
June 17, 2024
January 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of potentially actionable results based on pharmacogenomic (PGx) test
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.
Baseline
Secondary Outcomes (4)
The presence of at least one drug-gene interaction
Baseline, at 3 months and at 6 months after receiving the microarray profiling results
The presence of at least one PGx best practice advisory (BPA) alert
within 6 months of receiving the microarray profiling results
Percentage of prescriptions that trigger PGx best practice advisory (BPA) alerts
within 6 months of receiving the microarray profiling results
Taking actions from PGx best practice advisory alerts
within 6 months of receiving the microarray profiling results
Study Arms (1)
Pharmacogenomic Testing
OTHERA pharmacogenomic (PGx) microarray (multi-gene) panel will be performed to test for genetic variations in genes related to drug response.
Interventions
Pharmacogenomic (PGx) microarray testing will test for certain pharmcogenes that can guide prescribing of certain cancer treatments and/or supportive care medications.
Eligibility Criteria
You may qualify if:
- Written informed consent and HIPAA authorization for release of personal health information.
- Age ≥ 18 years at the time of consent.
- Willing to provide additional buccal swabs if residual DNA from previous DPYD testing is inadequate for microarray testing.
You may not qualify if:
- History of prior allogeneic hematopoietic cell transplantation or liver transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atrium Health Levine Cancer
Charlotte, North Carolina, 28204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jai Patel, PharmD
Atrium Health Levine Cancer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2024
First Posted
July 5, 2024
Study Start
July 18, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share