Evaluating Microarray Pharmacogenetic Testing in Cancer Patients

Last updated: January 30, 2026
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Abdominal Cancer

Stomach Cancer

Colorectal Cancer

Treatment

Pharmacogenomic Testing with the "Global Diversity Array with Enhanced PGx"

Clinical Study ID

NCT06489041
IRB00114240
LCI-GI-NOS-PGX-003
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Written informed consent and HIPAA authorization for release of personal healthinformation.

  • Age ≥ 18 years at the time of consent.

  • Eligible for standard of care single-gene DPYD testing (i.e., receiving or expectedto receive a fluoropyrimidine-based chemotherapy regimen). The potential participantmeets inclusion criteria if the standard of care single-gene DPYD test is planned orpreviously ordered. If previously ordered, consent must occur no later than 60 daysfrom the date the DPYD results were available.

  • Willing to provide additional buccal swabs if residual DNA from previous DPYDtesting is inadequate for microarray testing.

Exclusion

Exclusion Criteria:

• History of prior allogeneic hematopoietic cell transplantation or liver transplantation

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Pharmacogenomic Testing with the "Global Diversity Array with Enhanced PGx"
Phase:
Study Start date:
July 18, 2025
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Atrium Health Levine Cancer

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Atrium Health Levine Cancer

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Active - Recruiting

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