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

Trial Summary

What is the purpose of this trial?

Doctors leading this study hope to find out if giving study participants' genetic information to cancer care providers will help personalize chemotherapy dosing decisions and decrease common chemotherapy side effects. Doctors leading the study will collect genetic information from study participants using pharmacogenomics/genotyping. Pharmacogenomics is the study of how the differences in our genes can affect our unique response to medications. This is a randomized study, which means that participants in this study will be randomly assigned (as if "by flip of a coin") to one of two different groups: a "pharmacogenomics group" or "control group".

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 data supports the effectiveness of pharmacogenomic testing in cancer care?

Pharmacogenomic testing is seen as valuable by healthcare providers and consumers, with 72% of oncology providers believing it can improve care. However, there are barriers to its use, such as cost and lack of consistent guidelines, which need to be addressed for better implementation. ^{1 2 3 4 5}

Is pharmacogenomic testing generally safe for humans?

Pharmacogenomic testing is generally considered safe and is used to help predict how patients might respond to medications, including potential adverse effects. Studies have shown that medications with pharmacogenomic recommendations for safety are commonly prescribed, and testing can help align treatment with safety guidelines. ^{2 6 7 8 9}

How is Pharmacogenomic Testing for Cancer Care different from other treatments?

Pharmacogenomic Testing for Cancer Care is unique because it uses genetic information to tailor cancer treatment to the individual, potentially improving treatment response and reducing side effects. This personalized approach is part of precision medicine, which aims to optimize drug therapy based on a person's genetic makeup. ^{3 4 10 11 12}

Research Team

Peter O'Donnell, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Healthcare professionals' and consumers' knowledge, attitudes, perspectives, and education needs in oncology pharmacogenomics: A systematic review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Harnessing economic drivers for successful clinical implementation of pharmacogenetic testing. [2008]

3. United States pubmed.ncbi.nlm.nih.gov

Collaborative Counseling Considerations for Pharmacogenomic Tests. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Results of a nationwide survey of Japanese pharmacists regarding the application of pharmacogenomic testing in precision medicine. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Pharmacogenomic testing in oncology: a health system's approach to identify oncology provider perspectives. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Professional perspectives about pharmacogenetic testing and managing ancillary findings. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Prescription medications with actionable pharmacogenomic recommendations in Veterans Health Administration patients. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Public perspectives about pharmacogenetic testing and managing ancillary findings. [2021]

9. Japan pubmed.ncbi.nlm.nih.gov

A Pilot Study for Return of Individual Pharmacogenomic Results to Population-Based Cohort Study Participants. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Qualitative user evaluation of a revised pharmacogenetic educational toolkit. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of the need for pharmacogenomics testing among physicians in the West Bank of Palestine. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

Clinical Utilization of Pharmacogenetics in Psychiatry - Perspectives of Pharmacists, Genetic Counselors, Implementation Science, Clinicians, and Industry. [2021]