Evaluating Microarray Pharmacogenetic Testing in Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-18

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

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Cancer Gastrointestinal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pharmacogenomic Testing

A pharmacogenomic (PGx) microarray (multi-gene) panel will be performed to test for genetic variations in genes related to drug response.

Group Type OTHER

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

Intervention Type GENETIC

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

Interventions

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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.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* 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.