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Trial Title:
Evaluating Microarray Pharmacogenetic Testing in Cancer Patients
NCT ID:
NCT06489041
Condition:
Cancer
Gastrointestinal Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
Pharmacogenomic Testing with the "Global Diversity Array with Enhanced PGx"
Description:
Pharmacogenomic (PGx) microarray testing will test for certain pharmcogenes that can
guide prescribing of certain cancer treatments and/or supportive care medications.
Arm group label:
Pharmacogenomic Testing
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Atrium Health Levine Cancer
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Contact:
Last name:
Alicia Patrick
Phone:
980-292-1746
Email:
Alicia.Patrick@atriumhealth.org
Investigator:
Last name:
Jai Patel, PharmD
Email:
Principal Investigator
Start date:
November 2024
Completion date:
May 2025
Lead sponsor:
Agency:
Wake Forest University Health Sciences
Agency class:
Other
Collaborator:
Agency:
Atrium Health Levine Cancer Institute
Agency class:
Other
Source:
Wake Forest University Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06489041
