Trial Summary
What is the purpose of this trial?The study is enrolling adults who are scheduled for either inpatient or outpatient elective surgical procedures at The University of Chicago.
At pre-operative visits, patients will be consented and a blood sample will be obtained for preemptive genotyping across a panel of actionable germline variants predicting drug response or toxicity risk.
Genotyping results will be delivered to participating providers as patient-specific drug-gene clinical decision support summaries using a secured Web portal, the Genomic Prescribing System (GPS).
Participating anesthesiologists and critical care and pain management physicians and associated providers from the Department of Anesthesia and Critical Care at the University of Chicago will be invited to receive results for their participating patients.
There will be an initial 6- month "run-in" period of the study comprised of approximately 100 enrolled adults in which all patients will have pharmacogenomic results made available to providers. The run-in period will allow for process refinement and GPS delivery to be examined and optimized prior to the randomized phase
After the initial run-in period, patients will be randomized to one of two arms - in the pharmacogenomic arm, providers will have access to GPS and pharmacogenomic information, whereas in the control arm, providers will not have access to GPS and patient-specific pharmacogenomic information (current standard of care).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of genetic testing as a treatment for surgery?
Genetic testing helps identify patients with inherited genetic mutations, allowing for tailored preventive care and treatment, which can be beneficial in surgical settings. Surgeons can use genetic information to make informed decisions about patient care, potentially improving outcomes.
12345Is genetic testing for surgery safe for humans?
Research on elective surgeries shows that while complications can occur, most are mild and severe complications are rare. This suggests that the procedures, including any associated genetic testing, are generally safe for humans.
678910How is the treatment 'Routine Elective Surgery' unique compared to other treatments for this condition?
Routine elective surgery is unique because it involves planned surgical procedures that are not emergencies, allowing for preoperative evaluations and testing to ensure patient safety. Unlike other treatments that might be immediate or non-surgical, elective surgeries are scheduled in advance, providing time for thorough preparation and risk assessment.
1112131415Eligibility Criteria
Adults over 18 years old who are scheduled for elective surgery at the University of Chicago can join. They must be able to understand and agree to participate. People with past or active leukemia, or those considered for liver or kidney transplants cannot join.Inclusion Criteria
I am 18 years old or older.
I am an adult scheduled for surgery at the University of Chicago.
Exclusion Criteria
I have or had leukemia.
I am being considered for, or have had, a liver or kidney transplant.
I understand the study and can give my consent.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-operative
Patients are consented and a blood sample is obtained for preemptive genotyping
1 visit
1 visit (in-person)
Run-in
Initial 6-month period where pharmacogenomic results are made available to providers for process refinement
6 months
Randomized Treatment
Patients are randomized to either the pharmacogenomic arm or control arm for perioperative care
5 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
5 years
Participant Groups
The trial is testing if using a blood test to check how patients' genes affect their reaction to drugs (pharmacogenomics) before surgery can help doctors choose better medications. Initially, all will get this test, then they'll be randomly split into two groups: one where doctors see these genetics results and one where they don't.
3Treatment groups
Experimental Treatment
Group I: Pharmacogenomic (PGx) Arm [Randomization Arm 1]Experimental Treatment3 Interventions
All patients will undergo preemptive genotyping prior to their surgical procedure, and all patients will have pharmacogenomic results made available to providers.
Group II: Pain CohortExperimental Treatment3 Interventions
Patients with a post-operative pain consult will be included in a pain sub-analysis to assess pain scores, pain therapy administration, and rate of opioid-induced adverse events.
Group III: Control Arm [Randomization Arm 2]Experimental Treatment2 Interventions
All patients will undergo preemptive genotyping prior to their surgical procedure. Pharmacogenomic test results will not be made available to providers (standard of care). Genotyping results will be released to study providers (and patients) at the 6-month unblinding timepoint for patients in the control group.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University Of Chicago Medicine Comprehensive Cancer CenterChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
References
[Satisfaction after risk reducing mastectomy related to breast reconstruction surgery in patient with hereditary genetic mutation]. [2022]Patients with very high risk of cancer mutation may decide to undergo prophylactic surgery in order to avoid heavy clinical and radiological monitoring. This is a promising and nonetheless risky surgery because it is a complicated procedure and highly mutilating. Our goal was to improve the practice of this prophylactic surgery, to do so we assessed a postoperative satisfaction survey to cancer-free patients who have undergone this procedure.
Intentions for risk-reducing surgery among high-risk women referred for BRCA1/BRCA2 genetic counseling. [2021]Genetic testing for breast and ovarian cancer susceptibility is now part of routine clinical practice. Although rates of risk-reducing surgery following genetic testing have been increasing, little is known about attitudes toward risk-reducing surgery in women prior to genetic counseling and testing. This study examines correlates of patient intentions to undergo risk-reducing mastectomy (RRM) and risk-reducing oophorectomy (RRO).
Genetic testing for cancer susceptibility. [2018]Genetic testing for mutations in genes associated with an inherited predisposition to cancer is rapidly moving outside specialty genetic services and into mainstream health care. Surgeons, as front-line providers of cancer care, are uniquely positioned to identify those who may benefit from genetic testing and institute changes to their health care management based on those results. This article provides an overview of the critical elements of the process of genetic testing for cancer susceptibility.
Cancer Genetics. [2020]For most individuals, cancer development is multifactorial; however, up to 10% of all cancers are related to an inherited genetic mutation. As health care shifts to having a greater emphasis on prevention, care providers, including general surgeons, will need to play a role in identifying patients at high risk for cancer development. Genetic testing provides a tool to determine those patients with a genetic mutation and to whom appropriate preventive care and treatment may be offered. It is imperative for general surgeons to understand the role genetics plays in the care of individual patients and their relatives.
Ethics and genomic medicine, how to navigate decisions in surgical oncology. [2015]Using genetic information to make medical decisions and tailor treatments to individuals will likely provide major benefits and become an important part of health care. Surgical oncologists must ethically apply scientific genetic information in a complex and evolving environment to the benefit of their patients. In this review we address ethical issues associated with: indications for genetic testing, informed consent for testing and therapy, confidentiality, targeted therapy, prophylactic surgery, and genetic testing in children.
Adverse events in Victorian admissions for elective surgery. [2019]To investigate a method to identify and understand patterns of adverse events by utilising secondary data analysis; to identify the types of complications associated with elective surgery; to identify any specific "adverse event-prone" elective procedures; and to consider the implications of these patterns for hospital patient safety programs.
Perioperative risk assessment. The Project Perioperative Risk (PROPER). [2019]Surgical operations are preceded by an assessment of the anticipated risks for the patient due to the operation. The present assessment procedure is not optimally organised and the scientific base is weak. In this project a new organisation was tested that provides more relevant data on the risk and more optimal timing if the risk has to be modified. All elective patients from a defined geographical area (n = 1361) were seen one week before the operation for risk assessment. They were then followed up during and after the operation. About 30% of the operations were followed by complications. More than half of them were mild. Severe complications were rare. Three risk assessment classifications were tested. They were all fairly good estimators of the risk but had different properties. The next step in this project is to systematically evaluate the main risk-affecting factors to improve the quality of risk assessment.
The Nature and Severity of Adverse Events in Select Outpatient Surgical Procedures in the Veterans Health Administration. [2021]Research on adverse events (AEs) in outpatient surgery has been limited. As part of a Veterans Health Administration (VA) project on AE surveillance, we chart-reviewed selected outpatient surgical cases to characterize the nature and severity of AEs.
[Comparison of the "Trigger" tool with the minimum basic data set for detecting adverse events in general surgery]. [2018]Surgery is a high risk for the occurrence of adverse events (AE). The main objective of this study is to compare the effectiveness of the Trigger tool with the Hospital National Health System registration of Discharges, the minimum basic data set (MBDS), in detecting adverse events in patients admitted to General Surgery and undergoing surgery.
What can we learn from patient claims? - A retrospective analysis of incidence and patterns of adverse events after orthopaedic procedures in Sweden. [2021]Objective data on the incidence and pattern of adverse events after orthopaedic surgical procedures remain scarce, secondary to the reluctance for encompassing reporting of surgical complications. The aim of this study was to analyze the nature of adverse events after orthopaedic surgery reported to a national database for patient claims in Sweden.
Preoperative laboratory testing in children undergoing elective surgery: analysis of current practice. [2019]To evaluate current practice in preoperative testing of healthy children undergoing elective surgery that is not expected to result in significant blood loss.
Preoperative laboratory testing: should any tests be "routine" before surgery? [2019]Routine preoperative testing of all patients before elective surgery is unjustified. The frequency of unanticipated abnormalities or abnormalities shown to change patient management is too low to justify a practice pattern of testing all patients. Furthermore, little evidence exists that test result abnormalities are associated with perioperative morbidity. Table 12 lists a compilation of the findings from this article and recommendations regarding routine testing.
Diagnostic yield and costs associated with a routine pre-operative COVID-19 testing algorithm for asymptomatic patients prior to elective surgery. [2022]Infection with COVID-19 presents known and unknown perioperative risks to the patient and operative staff. Pre-operative testing protocols have become widespread, yet little is known about the utility of this practice in asymptomatic patients undergoing elective surgery. We describe the impact and cost of a routine testing protocol on elective surgical procedures in a retrospective series at a single institution.
[Preoperative testing routines for healthy, asymptomatic patients in the Canary Islands (Spain)]. [2018]To analyze patterns of routine testing before elective/scheduled surgery in healthy/asymptomatic patients classified as ASA I or II according to the American Society of Anesthesiologists.
Preoperative evaluation for gynecologic surgery: a guide to judicious, evidence-based testing. [2019]Preoperative testing is a routine component of surgical planning, however, the majority of literature agree that laboratory and diagnostic studies are over utilized. We aim to summarize the available literature and provide gynecologists performing elective surgery for benign indications guidance to determine when, in whom, and in what time frame preoperative studies should be collected.