Pharmacogenomic Testing for Cancer

Overseen By Megan Lattanze

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must be taking: Fluoropyrimidines

Disqualifiers: Prior transplants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new genetic test to determine its potential in helping doctors select and dose drugs for cancer patients. The test, called the Global Diversity Array with Enhanced PGx, examines many genes to understand how a person's body processes medicine. Cancer patients receiving or planning to receive a specific type of chemotherapy might qualify if they have already undergone a certain test or plan to do so soon. Eligible participants will provide a sample for this new genetic test. The goal is to improve treatment by tailoring it to each person’s genetic makeup. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could personalize cancer treatment for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this pharmacogenomic test is safe for cancer patients?

Research has shown that pharmacogenomics (PGx) testing, such as the Global Diversity Array with Enhanced PGx, is generally safe for patients. PGx testing examines genes to determine how individuals might react to certain medications. Since this test does not involve taking new drugs or treatments, the risk of side effects from the test itself is low.

Studies have found that PGx testing can assist doctors in selecting the right medications and doses, leading to safer and more effective treatment plans. The Global Diversity Array with Enhanced PGx is a widely used tool in this research, providing detailed genetic information that aids doctors in making better treatment decisions.

Overall, this genetic testing is well-tolerated and aims to improve medication prescription practices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pharmacogenomic testing for cancer because it offers a personalized approach to treatment. Unlike traditional cancer therapies, which often adopt a one-size-fits-all strategy, this method uses a microarray panel to identify genetic variations that affect how patients respond to drugs. This means doctors can tailor treatments to each individual's genetic makeup, potentially increasing effectiveness and reducing side effects. By understanding a patient's unique genetic profile, this approach promises more precise and efficient cancer care.

What evidence suggests that this pharmacogenomic testing is effective for cancer?

Research has shown that pharmacogenomic (PGx) testing can make drug use safer and more effective by considering a person's unique genetic makeup. In this trial, the Global Diversity Array with Enhanced PGx studies genetic differences affecting how cancer patients respond to medications. This testing helps doctors customize cancer treatments for each patient, potentially improving treatment results. Early findings suggest that PGx testing can help determine the right drug dose and reduce side effects, offering a more personalized approach to cancer care. ^{1 2 3 5 6}

Who Is on the Research Team?

Jai Patel, PharmD

Principal Investigator

Atrium Health Levine Cancer

Are You a Good Fit for This Trial?

This trial is for cancer patients eligible for DPYD gene testing, which helps tailor drug dosing. Specifics about who can join are not provided, but typically participants have a certain type of cancer and meet other health standards.

Inclusion Criteria

Written informed consent and HIPAA authorization for release of personal health information

I am set to receive or am currently on a chemotherapy that requires DPYD gene testing.

I am willing to give more cheek swabs if needed for DNA testing.

Exclusion Criteria

I have had a bone marrow or liver transplant in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pharmacogenomic Testing

A pharmacogenomic (PGx) microarray panel is performed to test for genetic variations in genes related to drug response

1 week

Follow-up

Participants are monitored for safety and effectiveness after receiving the microarray profiling results

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Global Diversity Array with Enhanced PGx

Trial Overview The study tests the 'Global Diversity Array with Enhanced PGx' microarray to see if it affects how doctors prescribe and dose cancer treatments compared to current single-gene testing methods.

How Is the Trial Designed?

Group I: Pharmacogenomic Testing Experimental Treatment 1 Intervention

A pharmacogenomic (PGx) microarray (multi-gene) panel will be performed to test for genetic variations in genes related to drug response.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Atrium Health Levine Cancer Institute

Collaborator

Trials

30

Recruited

4,700+

Citations

1. illumina.com illumina.com/products/by-type/microarray-kits/infinium-global-diversity-pgx.html

Infinium Global Diversity Array with Enhanced PGx Infinium Global Diversity Array (GDA) with Enhanced PGx is the most comprehensive genotyping microarray on the market for pharmacogenomics research.

2. illumina.com illumina.com/content/dam/illumina/gcs/assembled-assets/marketing-literature/infinium-global-diversity-array-with-enhanced-pgx-data-sheet-m-gl-00031/infinium-global-diversity-array-with-enhanced-pgx-data-sheet-M-GL-00031.pdf

Infinium™ Global Diversity Array with Enhanced PGx-8 v1.0 The Infinium Global Diversity Array with Enhanced PGx-8 v1.0 beadchip is the most comprehensive genotyping microarray on the market for supporting pharmacog ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06489041

Evaluating Microarray Pharmacogenetic Testing in 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10140932/

From Genetic Characterisation to Clinical Impact - PMC One of the main milestones of precision medicine is pharmacogenetics (PGx), which is the study of a patient's genomic data to achieve safer and more effective ...

5. frontiersin.org frontiersin.org/journals/genetics/articles/10.3389/fgene.2021.712602/full

Development and Implementation of In-House ... Pharmacogenomics (PGx) studies how a person's genes affect the response to medications and is quickly becoming a significant part of precision medicine.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/509116

Evaluating Microarray Pharmacogenetic Testing in 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 ...