Pharmacogenomic Testing for Cancer Care

Overseen By Peter O'Donnell, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must be taking: Fluoropyrimidine, Irinotecan

Disqualifiers: Blood cancer, Chronic kidney disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 15 months

860 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if genetic information can help doctors personalize chemotherapy doses and reduce side effects. Participants will either have their DNA tested and their treatment adjusted based on the results (Pharmacogenomics (PGx) Testing and Genomics Prescribing Information (GPS)) or receive standard treatment without genetic guidance. Adult cancer patients at The University of Chicago Medical Center, who plan to receive specific chemotherapy drugs like fluoropyrimidine or irinotecan and have not previously taken these drugs, might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to cutting-edge research that could lead to more personalized cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it focuses on patients who are planning to start treatment with specific chemotherapy drugs, so it's best to discuss your current medications with the trial team.

What prior data suggests that pharmacogenomic testing is safe for cancer care?

Research shows that genetic testing can make chemotherapy safer for patients. Studies have found that using genetic information to guide treatment lowers the risk of unwanted side effects from cancer drugs. For example, testing has been linked to fewer adverse reactions in patients.

Pharmacogenomics studies how a person's genes affect their response to drugs. By matching treatments to a person's genetic makeup, doctors can adjust chemotherapy doses to be safer and more effective. This means patients might experience fewer side effects, such as nausea or fatigue, that often accompany chemotherapy.

In summary, genetic testing has been shown to enhance cancer treatment safety by reducing harmful reactions. This approach offers promise for those seeking a better chemotherapy experience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pharmacogenomic testing in cancer care because it personalizes treatment by using a patient's unique genetic makeup to guide chemotherapy decisions. Unlike standard chemotherapy, which treats patients with a one-size-fits-all approach, this method allows doctors to tailor drug dosages and select treatments that are more likely to be effective and less likely to cause adverse effects. By providing immediate access to genetic information, this approach promises to optimize treatment efficacy and safety, potentially improving outcomes and quality of life for cancer patients.

What evidence suggests that pharmacogenomic testing could be effective for personalizing chemotherapy dosing in cancer care?

Research has shown that pharmacogenomics testing can tailor chemotherapy to individuals by using their unique genetic information to adjust drug doses. This method enhances the effectiveness of chemotherapy drugs and reduces side effects. In this trial, participants in the Pharmacogenomics Group will undergo pharmacogenomic testing, enabling doctors to adjust chemotherapy doses based on genetic results. Studies have found that genetic tests can improve treatment outcomes for certain cancer medications. For example, they help adjust doses of drugs like fluoropyrimidines and irinotecan, commonly used in chemotherapy. This testing aims to make treatments safer and more effective by ensuring each patient receives the appropriate medication dosage for their genetic makeup. ^{1 2 3 6 7}

Who Is on the Research Team?

Peter O'Donnell, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults at The University of Chicago Medical Center who need treatment with specific chemotherapy drugs (fluoropyrimidine and/or irinotecan) for various cancers. It's open to all genders, races, and ethnic groups. People can't join if they're in another study affecting drug doses, have had certain organ transplants or dysfunctions, don't understand the consent process, have blood cancer or chronic kidney disease, or have used these chemo drugs before.

Inclusion Criteria

I belong to any gender, race, or ethnic group.

I am an adult patient at The University of Chicago Medical Center and will be treated with fluoropyrimidine and/or irinotecan.

Exclusion Criteria

I am not in a trial that restricts changing doses of certain chemotherapies.

I have been treated with fluoropyrimidine or irinotecan before.

I understand and can consent to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either the pharmacogenomics group or control group to receive chemotherapy, with or without pharmacogenomic guidance.

15 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of toxicities and survival outcomes.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Availability of clinical decision support based on pharmacogenomic results
• Pharmacogenomics (PGx) Testing and Genomics Prescribing Information (GPS)

Trial Overview The study tests whether giving doctors genetic information about patients helps tailor chemotherapy doses to reduce side effects. Participants are randomly placed into two groups: one receives pharmacogenomic guidance for dosing; the other does not (control group).

How Is the Trial Designed?

Group I: Pharmacogenomics Group Experimental Treatment 1 Intervention

Participants enrolled in the pharmacogenomics group will give a DNA (deoxyribonucleic acid) sample for immediate pharmacogenomic genotyping. Once the genotyping results are in, cancer doctors caring for each participant will have immediate access to clinical decision support based on the participant's genetic results and can make dosing decisions/changes to the participant's chemotherapy prescription.

Group II: Control Group Active Control 1 Intervention

Participants assigned to the control group will receive standard chemotherapy without their doctors receiving any genetic information based on the participants' pharmacogenetic results. DNA (Deoxyribonucleic acid) samples for participants in this group will be stored and tested for genotyping six months later after treatment (or earlier if the participant experiences side effects).

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

Pharmacogenomic (PGx) testing is increasingly used in psychiatry to help guide medication decisions, potentially improving treatment response and identifying patients at risk for side effects.

Despite its benefits, the implementation of PGx testing in clinical practice faces challenges, and more research is needed to determine the best ways to integrate it into psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Utilization of Pharmacogenetics in Psychiatry - Perspectives of Pharmacists, Genetic Counselors, Implementation Science, Clinicians, and Industry. Brown, L., Eum, S., Haga, SB., et al.[2021]

Pharmacogenetic (PGx) testing can improve personalized medicine, but its uptake is hindered by a lack of understanding among both providers and patients, highlighting the need for better educational tools.

Feedback from pharmacists and the public indicated that three out of four components of a PGx educational toolkit were useful, emphasizing the importance of user input in creating effective resources for enhancing understanding and decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative user evaluation of a revised pharmacogenetic educational toolkit. Mills, R., Haga, SB.[2022]

Healthcare professionals (HCPs) and consumers recognize the value of pharmacogenomic (PGx) testing in oncology, but both groups face significant barriers to its implementation, such as costs and inconsistent guidelines.

A systematic review of 23 high-quality studies revealed that while there is a strong interest in PGx strategies, gaps in knowledge and practice among HCPs and concerns about test accuracy and confidentiality among consumers hinder the effective use of PGx in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare professionals' and consumers' knowledge, attitudes, perspectives, and education needs in oncology pharmacogenomics: A systematic review. Lim, CX., Bozkurt, A., Chen, ZY., et al.[2023]

Pharmacogenomic (PGx) testing is crucial for precision medicine, but its clinical implementation faces challenges that can be addressed through a multidisciplinary approach involving pharmacists and genetic counselors.

Effective PGx service delivery models that include patient education and counseling can help overcome obstacles and enhance the quality of care, ensuring that patients receive tailored treatments based on their genetic profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative Counseling Considerations for Pharmacogenomic Tests. Zierhut, HA., Campbell, CA., Mitchell, AG., et al.[2018]

A survey of 381 physicians in the West Bank of Palestine revealed that 81.1% had low exposure to pharmacogenomics (PGx) education, indicating a significant gap in their training regarding personalized medicine.

Over 90% of the physicians agreed that PGx should be included in medical school curricula, and 58.5% recognized its relevance to their practice, highlighting a strong demand for PGx education and testing implementation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the need for pharmacogenomics testing among physicians in the West Bank of Palestine. Jarrar, Y., Musleh, R., Hamdan, A., et al.[2021]

Health professionals showed a positive interest in pharmacogenetic (PGx) testing, but primary care physicians (PCPs) expressed concerns about its clinical utility, insurance coverage, and the complexities of communicating incidental disease risk information.

The study highlighted a need for better educational resources and clear guidelines to help PCPs effectively use PGx testing, as many felt obligated to disclose ancillary disease risks but were unsure how to interpret these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Professional perspectives about pharmacogenetic testing and managing ancillary findings. Haga, SB., Tindall, G., O'Daniel, JM.[2021]

In a study involving 161 participants, returning pharmacogenomic (PGx) testing results for actionable genes led to over 80% of participants feeling satisfied and knowledgeable about how this information could benefit their future medication prescriptions.

Despite the overall positive reception, some participants found the PGx concepts challenging to understand, indicating a preference for in-person discussions when receiving their results, which highlights the need for effective communication in genetic testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study for Return of Individual Pharmacogenomic Results to Population-Based Cohort Study Participants. Ohneda, K., Hiratsuka, M., Kawame, H., et al.[2022]

In a review of outpatient prescriptions from 2011 to 2021 at the Veterans Health Administration, 32.8% of medications had actionable pharmacogenomic (PGx) recommendations, indicating a significant prevalence of medications that could be optimized based on genetic testing.

Among patients who experienced adverse drug reactions (ADRs) related to PGx-impacted medications, 39.1% had PGx results that matched the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines, highlighting the potential for PGx testing to improve medication safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescription medications with actionable pharmacogenomic recommendations in Veterans Health Administration patients. Maghari, S., Gallo, T., Rivas, S., et al.[2023]

A focus group study with 45 participants showed strong enthusiasm for pharmacogenetic (PGx) testing, indicating a positive public attitude towards its potential to improve treatment outcomes.

Participants expressed concerns about privacy and the psychological impact of receiving unexpected ancillary disease risk information, highlighting the need for clear communication between patients and healthcare providers regarding the benefits and risks of PGx testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public perspectives about pharmacogenetic testing and managing ancillary findings. Haga, SB., Tindall, G., O'Daniel, JM.[2021]

Pharmacogenetic (PGx) testing needs to establish clear links between genetic variations and medication responses in specific populations, along with valid tests to measure these variations, before it can significantly impact clinical practice.

There is a pressing need for research to evaluate whether PGx testing actually improves patient health outcomes and is cost-effective compared to standard care, as this information is crucial for clinicians and payers to adopt PGx testing in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing economic drivers for successful clinical implementation of pharmacogenetic testing. Deverka, PA., McLeod, HL.[2008]

A survey of 1,313 pharmacists in Japan showed that while most recognize the importance of pharmacogenomics (PGx) testing for personalized medicine, only 26% are currently involved in its implementation.

The main barrier to PGx testing is the lack of insurance coverage, and there is a significant need for better education on PGx, as only 12.4% of pharmacists have received specific training in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a nationwide survey of Japanese pharmacists regarding the application of pharmacogenomic testing in precision medicine. Tsuji, D., Saito, Y., Mushiroda, T., et al.[2021]

A survey of 25 oncology providers revealed that 88% were aware of pharmacogenomic (PGx) testing, and 72% believed it could enhance patient care, indicating a strong interest in personalized medicine.

Providers who had received prior education on PGx were significantly more likely to order PGx tests, suggesting that increasing educational efforts could improve the adoption of PGx testing in prescribing anticancer and supportive care medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenomic testing in oncology: a health system's approach to identify oncology provider perspectives. Bhatt, M., Peshkin, BN., Kazi, S., et al.[2023]

Citations

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Implementation of pharmacogenomic testing in oncology ... Pharmacogenomics (PGx) has promise to personalize chemotherapy drug dosing to maximize efficacy and safety. Fluoropyrimidines and irinotecan have well-known ...

2. thermofisher.com thermofisher.com/blog/clinical-conversations/pharmacogenomics-testing-in-oncology/

Pharmacogenomics Testing in Oncology PGx testing can maximize chemotherapy drug efficacy. · PGx testing can reduce adverse reactions to chemotherapy drugs.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11943113/

Implementation of Pharmacogenomics Testing in Daily ... Many studies, including randomized clinical trials, have demonstrated that PGx-guided treatment can improve clinical outcomes for some drugs ( ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.02761

Large-Scale Pharmacogenomics Analysis of Patients With ... We set out to assess the potential viability and clinical impact of reporting genetic variants associated with drug-induced toxicity for patients with cancer.

5. incitehealth.com incitehealth.com/how-pharmacogenomics-pgx-testing-is-transforming-cancer-care/

How Pharmacogenomics (PGx) Testing is Transforming ... PGx represents a transformative approach in cancer treatment that utilizes the genetic makeup of both the patient and their cancer to personalize and optimize ...

6. nature.com nature.com/articles/s41397-024-00326-1

a reality for future health care | The Pharmacogenomics ... The trial results demonstrated a significant reduction in the incidence of ADRs associated with PGx testing. Patients who underwent testing had ...

7. fightcancer.org fightcancer.org/sites/default/files/pgx_recommendations_final_edit_acs_can_6.pdf

PGx Recommendations Final Edit ACS CAN Several well-characterized examples show how PGx influences the effectiveness and safety of drugs used to treat patients with cancer.