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NCT03729180NARecruitingAccepts Healthy Volunteers

The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery

University of Chicago

Start Date

1/22/2019

Completion Date

8/22/2027

Summary

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).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Adult patients who have planned elective surgical procedures at the University of Chicago * Must be aged 18 years or older Exclusion Criteria: * Patients who have undergone, or are being actively considered for, liver or kidney transplantation * Patients with known active or prior leukemia. * Inability to understand and give informed consent to participate.

Interventions

PROCEDURE

Routine Elective Surgery- In patient or out patient elective surgery

DIAGNOSTIC_TEST

Blood test for genetic testing

OTHER

Drug-genetic Profile

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Conditions

Surgery

Locations

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois 60637

United States