Status:
RECRUITING
Evaluating Microarray Pharmacogenetic Testing in Cancer Patients
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Atrium Health Levine Cancer Institute
Conditions:
Cancer
Gastrointestinal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 dehyd...
Eligibility Criteria
Inclusion
- 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
- • History of prior allogeneic hematopoietic cell transplantation or liver transplantation
Key Trial Info
Start Date :
July 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06489041
Start Date
July 18 2025
End Date
December 1 2026
Last Update
July 22 2025
Active Locations (1)
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1
Atrium Health Levine Cancer
Charlotte, North Carolina, United States, 28204