Clinical trial NCT06489041: Evaluating Microarray Pharmacogenetic Testing in Cancer Patients
Official title: Evaluating the Use of Microarray Pharmacogenetic Testing in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Gastrointestinal Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
First posted: 2024-07-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of potentially actionable results based on pharmacogenomic (PGx) test
timeFrame: Baseline
Secondary outcomes:
measure: The presence of at least one drug-gene interaction
timeFrame: Baseline, at 3 months and at 6 months after receiving the microarray profiling results
measure: The presence of at least one PGx best practice advisory (BPA) alert
timeFrame: within 6 months of receiving the microarray profiling results
measure: Percentage of prescriptions that trigger PGx best practice advisory (BPA) alerts
timeFrame: within 6 months of receiving the microarray profiling results
measure: Taking actions from PGx best practice advisory alerts
timeFrame: within 6 months of receiving the microarray profiling results
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health Levine Cancer
state: North Carolina
Study officials:
affiliation: Atrium Health Levine Cancer
name: Jai Patel, PharmD
role: PRINCIPAL_INVESTIGATOR
References: