Ignite Creation Date:
2024-07-17 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489041
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-17
Brief Title:
Evaluating Microarray Pharmacogenetic Testing in Cancer Patients
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Evaluating the Use of Microarray Pharmacogenetic Testing in Patients With Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to evaluate the impact of a microarray PGx test on prescribingdosing 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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LCI-GI-NOS-PGX-003 | OTHER | None | None |