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OpenTrials
Active, Not Recruiting

NCT Number: NCT06489041

Evaluating Microarray Pharmacogenetic Testing in Cancer Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Levine Cancer

Charlotte, North Carolina, 28204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Genetic

Pharmacogenomic (PGx) microarray testing will test for certain pharmcogenes that can guide prescribing of certain cancer treatments and/or supportive care medications.

Primary outcomes

  1. Number of potentially actionable results based on pharmacogenomic (PGx) test

    Time frame: 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 outcomes

  1. The presence of at least one drug-gene interaction

    Time frame: 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).

  2. The presence of at least one PGx best practice advisory (BPA) alert

    Time frame: 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).

  3. Percentage of prescriptions that trigger PGx best practice advisory (BPA) alerts

    Time frame: 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

  4. Taking actions from PGx best practice advisory alerts

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Atrium Health Levine Cancer Institute

Registry information

Official study title

Evaluating the Use of Microarray Pharmacogenetic Testing in Patients With Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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