NCT06489041

Evaluating Microarray Pharmacogenetic Testing in Cancer Patients

Evaluating the Use of Microarray Pharmacogenetic Testing in Patients With Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Gastrointestinal Cancer

Interventions

Type	Name	Description
GENETIC	Pharmacogenomic 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.

Timeline

• Start date: 2025-07-18
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-07-05
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States