Pharmacogenomic Testing for Cancer Care
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Chicago
Must be taking: Fluoropyrimidine, Irinotecan
Disqualifiers: Blood cancer, Chronic kidney disease, others
No Placebo Group
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.
12345Is 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.
26789How 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.
34101112Eligibility 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.
+5 more
Trial 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
Participant Groups
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).
2Treatment groups
Experimental Treatment
Active Control
Group I: Pharmacogenomics GroupExperimental Treatment1 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 GroupActive Control1 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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Chicago Medical CenterChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
References
Healthcare professionals' and consumers' knowledge, attitudes, perspectives, and education needs in oncology pharmacogenomics: A systematic review. [2023]Clinical implementation of pharmacogenomic (PGx)-guided prescribing in oncology lags behind research evidence generation. We aimed to identify healthcare professionals' (HCPs) and consumers' knowledge, attitudes, perspectives, and education needs to inform strategies for implementation of scalable and sustainable oncology PGx programs. Systematic review of original articles indexed in EMBASE, EMCARE, MEDLINE, and PsycInfo from January 2012 until June 2022, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and using the Mixed Methods Appraisal Tool. PROSPERO registration number CRD42022352348. Of 1442 identified studies; 23 met inclusion criteria with 87% assessed high quality. Of these, 52% reported on HCPs, 35% on consumers, and 13% on both HCPs and consumers. Most were conducted in the United States (70%) and included multiple cancer types (74%). Across studies, HCPs and consumers mostly perceived value in PGx, however, both groups reported barriers to utilization, including cost, lack of consistent recommendations across guidelines, and limited knowledge among HCPs; test accuracy, clear testing benefits, and genomic information confidentiality among consumers. HCPs and consumers value and want to engage in PGx strategies in oncology care, however, are inhibited by unmet needs and practice and knowledge gaps. Implementation strategies aimed at addressing these issues may best support increased PGx uptake in oncology practice.
Harnessing economic drivers for successful clinical implementation of pharmacogenetic testing. [2008]Before pharmacogenetic (PGx) testing has a major impact on clinical practice, two levels of evidence must be generated. First, studies demonstrating the links between genetic variation and response to medications in defined populations are needed, along with development of valid tests to measure these specific variants. Second, studies should be conducted to evaluate whether PGx testing improves health outcomes for patients and whether the decision to test is cost-effective relative to usual care. This latter set of questions is typically of greatest relevance to clinicians and payers, the ultimate gatekeepers for the clinical integration of pharmacogenetics. To date, nearly all of the research efforts and funding for PGx have been focused on the first set of issues-getting the science right. However, now is the time to increase our research efforts on the second set of issues-to improve the PGx evidence base for both clinical and economic decision making.
Collaborative Counseling Considerations for Pharmacogenomic Tests. [2018]Increased use of pharmacogenomic (PGx) testing in the clinical setting has revealed a number of challenges to providing this service. PGx is an important component of precision medicine that brings together the fields of genetics and clinical pharmacology. A model that incorporates a multidisciplinary approach to implementation and information delivery may be the most beneficial to patients and providers. In this review, translational considerations in the provision of PGx testing and counseling services are described. Specifically, we report on the selection of PGx tests, the provision of patient education and counseling, and examples of PGx service delivery models that incorporate counseling by pharmacists and genetic counselors. Examples of ancillary risks associated with PGx testing, testing of children, and familial implications of testing are reviewed. Through multispecialty partnerships, including genetic counselors and pharmacists, implementation obstacles to PGx testing can be overcome to provide quality precision medicine to patients.
Results of a nationwide survey of Japanese pharmacists regarding the application of pharmacogenomic testing in precision medicine. [2021]Pharmacogenomics (PGx) testing can be effective for supporting precision medicine. The purpose of this study was to assess the knowledge, attitude and practice behaviours of pharmacists in relation to such testing through a survey. We also aimed to identify potential obstacles to implementation of PGx testing by pharmacists and the characteristics of hospital pharmacists involved.
Pharmacogenomic testing in oncology: a health system's approach to identify oncology provider perspectives. [2023]Aim: Identify oncology healthcare providers' attitudes toward barriers to and use cases for pharmacogenomic (PGx) testing and implications for prescribing anticancer and supportive care medications. Materials & methods: A questionnaire was designed and disseminated to 71 practicing oncology providers across the MedStar Health System. Results: 25 of 70 (36%) eligible oncology providers were included. 88% were aware of PGx testing and 72% believed PGx can improve care. Of providers who had ordered a medication with PGx implications in the past month, interest in PGx for anticancer (90-100%) and supportive care medications (>75%) was high. Providers with previous PGx education were more likely to have ordered a test (odds ratio: 7.9; 95% CI: 1.1-56; p = 0.0394). Conclusion: Oncology provider prescribing practices and interest in PGx suggest opportunities for implementation.
Professional perspectives about pharmacogenetic testing and managing ancillary findings. [2021]Pharmacogenetic (PGx) tests, intended to inform therapeutic decision making through prediction of patient likelihood to respond to or experience an adverse effect from a specific treatment, may also generate ancillary, or incidental, disease information unrelated to the purpose for which the test was ordered. To assess attitudes toward PGx testing, ancillary disease risk information, and related clinical issues, we conducted a series of focus groups among health professionals.
Prescription medications with actionable pharmacogenomic recommendations in Veterans Health Administration patients. [2023]Aim: To evaluate the prevalence of medications with actionable pharmacogenomic (PGx) safety and efficacy recommendations in patients receiving care from the Veterans Health Administration. Materials & methods: Outpatient prescription data from 2011 to 2021 and any documented adverse drug reactions (ADRs) were reviewed for those who received PGx testing at one Veterans Administration location between November 2019 and October 2021. Results: Among the reviewed prescriptions, 381 (32.8%) were associated with an actionable recommendation based on the Clinical Pharmacogenetics Implementation Consortium (CPIC) prescribing guidelines, with 205 (17.7%) for efficacy concerns and 176 (15.2%) for safety concerns. Among those with a documented ADR for a PGx-impacted medication, 39.1% had PGx results that aligned with CPIC recommendations. Conclusion: Medications with actionable PGx recommendations for safety and efficacy concerns are received with similar frequency, and most patients who have undergone PGx testing at the Phoenix Veterans Administration have received medications that may be impacted by PGx testing.
Public perspectives about pharmacogenetic testing and managing ancillary findings. [2021]Pharmacogenetic (PGx) tests are intended to improve therapeutic outcomes through predicting a patient's likelihood to respond to or experience an adverse effect from a specific treatment. In addition, PGx testing may also generate ancillary, or incidental, disease information unrelated to the purpose for which the test was ordered. To assess public attitudes toward PGx testing, ancillary disease risk information and related clinical issues, we conducted a series of focus groups.
A Pilot Study for Return of Individual Pharmacogenomic Results to Population-Based Cohort Study Participants. [2022]Pharmacogenomic (PGx) testing results provide valuable information on drug selection and appropriate dosing, maximization of efficacy, and minimization of adverse effects. Although the number of large-scale, next-generation-sequencing-based PGx studies has recently increased, little is known about the risks and benefits of returning PGx results to ostensibly healthy individuals in research settings.
Qualitative user evaluation of a revised pharmacogenetic educational toolkit. [2022]Pharmacogenetic (PGx) testing is a leading application for personalized and precision medicine; however, there are barriers, including limited provider and patient understanding, which affect its uptake. There is a need for tools that can enhance the patient and provider experience with testing and promoting the shared and informed decision-making.
Evaluation of the need for pharmacogenomics testing among physicians in the West Bank of Palestine. [2021]Pharmacogenomics (PGx) testing optimizes pharmacotherapy and reduces interindividual variation in drug responses. However, it is still not implemented in clinical practice in the West Bank of Palestine (WBP). The aim of this study was to determine the need for PGx education and testing among physicians from different specialties in WBP.
Clinical Utilization of Pharmacogenetics in Psychiatry - Perspectives of Pharmacists, Genetic Counselors, Implementation Science, Clinicians, and Industry. [2021]The use of pharmacogenomic (PGx) testing to guide decisions and improve patient outcomes has increased in recent years. PGx testing represents a decision support tool that may inform dosing, increase the likelihood of treatment response, and identify patients at risk for medication side effects.