R01HG012273

Pharmacogenomics to Catalyze Decision Support in Oncology Care - Project Summary/Abstract

Patients with cancer represent one of the most vulnerable populations in our healthcare system. Not only do such individuals face a life-threatening diagnosis, but the toxicities of treatment regimens place cancer patients at additional risk for adverse outcomes.

Additionally, most cancer patients experience inadequately treated pain, despite pharmacologic interventions by clinicians to address pain. The use of germline pharmacogenomic information offers a potential solution to better inform therapeutic decision-making. Many consider it an ideal discipline by which to advance and examine the clinical application of genomic medicine.

Nevertheless, preemptive germline pharmacogenomic testing does not currently constitute the standard of care before utilization of most anti-cancer therapies, nor for pain prescribing. One of the most frequently cited reasons is the lack of prospective randomized data demonstrating its utility.

We posit that preemptive genotyping and the upfront use of pharmacogenomic information offers the potential to improve cancer care. We hypothesize that providing germline pharmacogenomic information along with clinical decision support will guide personalized chemotherapy and pain medication choices and dosing decisions, reduce toxicity, and result in improved patient outcomes.

We propose to leverage our existing institutional infrastructure and two strengths of the University of Chicago (pharmacogenomics, oncology) by performing the first known broad prospective randomized studies of germline pharmacogenomics in oncology. We will recruit patients preparing to initiate cancer chemotherapy or pain treatment who have one of three major cancer types (gastrointestinal, head and neck, or breast malignancies), and randomize to upfront pharmacogenomic testing versus no upfront pharmacogenomic information (usual care).

Chemotherapy dosing and the incidence of severe toxicities, as well as opioid selection for pain treatment and pain medication response, will be compared between arms. Additionally, we will evaluate whether sharing of pharmacogenomic results with patients in an informed manner improves patients' knowledge about and perceptions of treatment choices and alignment with treatment goals.

In summary, this proposal will examine and advance the idea that widespread efficacious clinical translation of genomic discoveries will be actualized both by systems/technology changes as well as the strategic assessment of genomic knowledge applications within key clinical settings and stakeholder populations. Future effectiveness and impact on public health will result not just from the findings we generate but from an improved understanding of decision-making processes involved in promoting and adopting risk-reductive, customized treatment practices.

University Of Chicago

AS A LEADING AUTHORITY IN THE FIELD OF GENOMICS, THE MISSION OF THE NATIONAL HUMAN GENOME RESEARCH INSTITUTE (NHGRI) IS TO ACCELERATE SCIENTIFIC AND MEDICAL BREAKTHROUGHS THAT IMPROVE HUMAN HEALTH BY DRIVING CUTTING-EDGE RESEARCH, DEVELOPING NEW TECHNOLOGIES, AND STUDYING THE IMPACT OF GENOMICS ON SOCIETY. CONGRESS INITIALLY ESTABLISHED NHGRI TO CHARACTERIZE THE STRUCTURE AND FUNCTION OF THE HUMAN GENOME, INCLUDING THE MAPPING AND SEQUENCING OF INDIVIDUAL GENES. THIS ALSO INCLUDES REVIEWING AND FUNDING RESEARCH PROPOSALS, DEVELOPING TRAINING PROGRAMS, COORDINATING INTERNATIONAL GENOME RESEARCH, COMMUNICATING ADVANCES IN GENOME SCIENCE TO THE PUBLIC, AND REVIEWING AND FUNDING PROPOSALS TO ADDRESS THE ETHICAL AND LEGAL ISSUES ASSOCIATED WITH THIS RESEARCH.NHGRI SUPPORTS THE DEVELOPMENT OF METHODS, RESOURCES AND TECHNOLOGIES TO IMPROVE THE HEALTH OF ALL HUMANS THROUGH ADVANCES IN GENOMICS RESEARCH. NHGRI SUPPORTS RESEARCH THAT ACCELERATES FOUNDATIONAL RESOURCES, TECHNOLOGY DEVELOPMENT, AND EXPERIMENTAL AND COMPUTATIONAL APPROACHES FOR BASIC GENOMICS AND FUNCTIONAL GENOMICS RESEARCH; FOR THE APPLICATION OF GENOMICS TO MEDICAL SCIENCE AND CLINICAL CARE; AND TO SUPPORT ETHICAL, LEGAL AND SOCIAL IMPLICATIONS (ELSI) RESEARCH CONCERNING SOCIETAL ISSUES THAT NEED TO BE ADDRESSED, ESPECIALLY AS GENOMIC SCIENCE ADVANCES. FOR YEARS, NHGRI HAS PARTICIPATED IN THE NIH EFFORT TO TURN DISCOVERY INTO HEALTH BY HELPING SMALL BUSINESSES DEVELOP INNOVATIVE GENOMICS TECHNOLOGIES THAT IMPROVE HEALTH AND SAVE LIVES. NHGRI ALSO DEVELOPS AND SUPPORTS INITIATIVES THAT EXPAND OPPORTUNITIES FOR GENOMICS EDUCATION AND CAREERS, CULTIVATING GENOMICS TRAINING PROGRAMS AND WORKFORCE DEVELOPMENT INITIATIVES.

93.172 - Human Genome Research

National Human Genome Research Institute (NHGRI) [HHS - NIH]

Chicago, Illinois 606375418 United States

Single Zip Code

Advancing Genomic Medicine Research (Clinical Trial Optional) (R01) (RFA-HG-20-036)

Amendment Since initial award the total obligations have increased 294% from $884,216 to $3,487,353.