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NCT Number: NCT03729180

The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery

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).

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Emily Schierer

CONTACT

[email protected]

773-753-1200

Peter O'Donnell, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine Elective Surgery- In patient or out patient elective surgery

Procedure

Participants will be undergoing routine planned surgeries.

Blood test for genetic testing

Diagnostic Test

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

Other

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 outcomes

  1. 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

    To explore the feasibility and utility of implementing broad preemptive pharmacogenomic testing in the perioperative setting by determining the frequency of Genomic Prescribing System (GPS) use by anesthesiologists and pain medicine physicians and associated providers during the perioperative period.

  2. Rate of use of high-risk drugs in perioperative setting

    Time frame: 5 years

    To determine the rate of use high-risk drugs (red or yellow pharmacogenomic risk) in the group of patients for whom pharmacogenomic results are available compared to their rate of use (without provider knowledge of pharmacogenomic risk designation) in the control arm.

Secondary outcomes

  1. Rate of use of favorable drugs in perioperative setting

    Time frame: 5 years

    To determine the occurrence of specific pharmacogenomically-informed adverse drug events in both arms.

  2. Occurrence of specific pharmacogenomically-informed adverse drug events

    Time frame: 5 years

    To determine the occurrence of specific pharmacogenomically-informed adverse drug events in both arms.

  3. Pharmacogenomic result availability on pain management services in both arms using a research database for each patient

    Time frame: 5 years

    To explore the effects of pharmacogenomic result availability on pain management services in both arms.

  4. Comparison of pain scores on a 10 point scale

    Time frame: 5 years

    To compare pain scores between both arms.

  5. Anesthesia and critical care providers knowledge and perceptions of prescribing decisions using a information provided in research database

    Time frame: 5 years

    To determine anesthesia and critical care providers' knowledge and perceptions of prescribing decisions in order to develop better genomic delivery systems in the future

  6. Differences in patient reported satisfaction using research database

    Time frame: 5 years

    To determine whether differences in patient-reported satisfaction and adherence likelihood are observable for patients whose providers access and use pharmacogenomic information.

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer Clinical Trials Office

CONTACT

[email protected]

1-855-702-8222

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Human Genome Research Institute (NHGRI)

Registry information

Official study title

The ImPreSS Trial: Implementation of Point-of-Care Pharmacogenomic Decision Support in Perioperative Care

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Nov 2, 2018
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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