CancerNCT06489041
Evaluating Microarray Pharmacogenetic Testing in Cancer Patients
A study testing Pharmacogenomic Testing with the "Global Diversity Array with Enhanced PGx" in people with Cancer and Gastrointestinal Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Gastrointestinal Cancer
- What is being tested?
- Pharmacogenomic Testing with the "Global Diversity Array with Enhanced PGx"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2025to 6 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of prior allogeneic hematopoietic cell transplantation or liver transplantation
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Levine Cancer
Charlotte, North Carolina, 28204
About this study
Official title: Evaluating the Use of Microarray Pharmacogenetic Testing in Patients With Cancer
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.
Read the 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.
- Conditions
- Cancer, Gastrointestinal Cancer
- Being tested
- Pharmacogenomic Testing with the "Global Diversity Array with Enhanced PGx"
- Medical subject headings
- Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomic Testing with the "Global Diversity Array with Enhanced PGx"Genetic
Pharmacogenomic (PGx) microarray testing will test for certain pharmcogenes that can guide prescribing of certain cancer treatments and/or supportive care medications.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacogenomic Testing | Other | A pharmacogenomic (PGx) microarray (multi-gene) panel will be performed to test for genetic variations in genes related to drug response. Receives: Genetic: Pharmacogenomic Testing with the "Global Diversity Array with Enhanced PGx" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of potentially actionable results based on pharmacogenomic (PGx) test
A potentially actionable result refers to any genotype or phenotype that is associated with specific drug-gene interactions from the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines or the FDA's Table of Pharmacogenetic Associations. The number of potentially actionable results is a count variable that represents the total occurrences of such genotypes or phenotypes identified in a participant.
Measured: Baseline
Secondary outcomes (4)
The presence of at least one drug-gene interaction
Drug-gene interactions is defined as an interaction between the medication(s) taken by the subject and the genetic variant(s) the subject possesses based on the PGx test. The presence or absence of such interactions is assessed using the guidelines provided by the Clinical Pharmacogenetics Implementation Consortium (CPIC) or the FDA's Table of Pharmacogenetic Associations. The presence of at least one drug-gene interaction is a binary variable (yes/no).
Measured: Baseline, at 3 months and at 6 months after receiving the microarray profiling results
The presence of at least one PGx best practice advisory (BPA) alert
BPA alert is fired within the Epic electronic health record (EHR) system for the participant when there is presence of a drug-gene interaction at the time of medication order entry. The presence of at least one PGx best practice advisory (BPA) alert for each participant is a binary variable (yes, no).
Measured: within 6 months of receiving the microarray profiling results
Percentage of prescriptions that trigger PGx best practice advisory (BPA) alerts
Percentage of prescriptions that trigger PGx best practice advisory (BPA) alert among all prescriptions for each participant
Measured: within 6 months of receiving the microarray profiling results
Taking actions from PGx best practice advisory alerts
Taking actions after receiving PGx best practice advisory alerts includes remove or keep drug, order or do not order an e-consult, patient previously tolerated/responded treatment, not appropriate, or other. Taking actions is a binary variable (yes, no).
Measured: within 6 months of receiving the microarray profiling results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start18 Jul 2025
- Primary completion6 May 2026
- Study completion6 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Jai Patel, PharmD, Principal investigator, Atrium Health Levine Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489041
- Sponsor's protocol ID
- IRB00114240
- Other IDs
- LCI-GI-NOS-PGX-003
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Microarray Pharmacogenetic Testing in Patients With Cancer
- ClinicalTrials.gov ID
- NCT06489041
- Acronym / sponsor ID
- IRB00114240
- Conditions
- Cancer, Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 Nov 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Pharmacogenomic Testing | Other | Genetic: Pharmacogenomic Testing with the "Global Diversity Array with Enhanced PGx"A pharmacogenomic (PGx) microarray (multi-gene) panel will be performed to test for genetic variations in genes related to drug response. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- History of prior allogeneic hematopoietic cell transplantation or liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Genetic | Pharmacogenomic Testing |
Primary outcome
Number of potentially actionable results based on pharmacogenomic (PGx) test
Time frame: Baseline
A potentially actionable result refers to any genotype or phenotype that is associated with specific drug-gene interactions from the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines or the FDA's Table of Pharmacogenetic Associations. The number of potentially actionable results is a count variable that represents the total occurrences of such genotypes or phenotypes identified in a participant.
4 secondary outcomes
The presence of at least one drug-gene interaction
Time frame: Baseline, at 3 months and at 6 months after receiving the microarray profiling results
The presence of at least one PGx best practice advisory (BPA) alert
Time frame: within 6 months of receiving the microarray profiling results
Percentage of prescriptions that trigger PGx best practice advisory (BPA) alerts
Time frame: within 6 months of receiving the microarray profiling results
Taking actions from PGx best practice advisory alerts
Time frame: within 6 months of receiving the microarray profiling results
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jai Patel, PharmD principal investigator
Atrium Health Levine Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenomic Testing with the "Global Diversity Array with Enhanced PGx" in people with Cancer and Gastrointestinal Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of potentially actionable results based on pharmacogenomic (PGx) test (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.