Recruiting

Pharmacogenomic Decision Making

Sponsor:

University of Chicago

Code:

NCT03729180

Conditions

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Routine Elective Surgery- In patient or out patient elective surgery

Blood test for genetic testing

Drug-genetic Profile

Study Details

Brief 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).

Conditions

Surgery

Study ID

NCT03729180

Start date

Jan 22, 2019

Status verified date

Dec, 2025

Completion date

Aug 22, 2027

Anticipated

Primary completion date

Aug 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1900 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Pain Cohort

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.

experimental: Pharmacogenomic (PGx) Arm [Randomization Arm 1]

All patients will undergo preemptive genotyping prior to their surgical procedure, and all patients will have pharmacogenomic results made available to providers.

other: Control Arm [Randomization Arm 2]

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.

Interventions

Routine Elective Surgery- In patient or out patient elective surgery

Participants will be undergoing routine planned surgeries.

Blood test for genetic testing

Blood test to determine differences in genes which may affect how certain medications affect the participant. All patients will consent to collection of a blood sample for preemptive genotyping across a panel of actionable germline variants predicting drug response or toxicity risk.

Drug-genetic Profile

Profile describing drugs that may be high-risk, those that should be used with caution, or drugs that are favorable to use based on the participants genes.

Primary outcome measure

  • The frequency of Genomic Prescribing System (GPS) use by anesthesiologists and pain medicine physicians and associated providers during the perioperative period. [ Time Frame: 5 years ]
  • Rate of use of high-risk drugs in perioperative setting [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

University Of Chicago Medicine Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Peter O'Donnell, MD

More Information

Sponsor

University of Chicago

Last update posted

Apr 24, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-04-24.