The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery
NCT ID: NCT03729180
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1900 participants
INTERVENTIONAL
2019-01-22
2027-08-22
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Must be aged 18 years or older
Exclusion Criteria
* Patients with known active or prior leukemia.
* Inability to understand and give informed consent to participate.
18 Years
ALL
Yes
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Peter O'Donnell
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University Of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Emily Schierer
Role: primary
References
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Truong TM, Apfelbaum JL, Danahey K, Schierer E, Ludwig J, George D, House L, Karrison T, Shahul S, Anitescu M, Choksi A, Hartman S, Knoebel RW, van Wijk XMR, Yeo KJ, Meltzer DO, Ratain MJ, O'Donnell PH. Pilot Findings of Pharmacogenomics in Perioperative Care: Initial Results From the First Phase of the ImPreSS Trial. Anesth Analg. 2022 Nov 1;135(5):929-940. doi: 10.1213/ANE.0000000000005951. Epub 2022 Feb 25.
Truong TM, Apfelbaum JL, Schierer E, Danahey K, Borden BA, Karrison T, Shahul S, Anitescu M, Gerlach R, Knoebel RW, Meltzer DO, Ratain MJ, O'Donnell PH. Anesthesia providers as stakeholders to adoption of pharmacogenomic information in perioperative care. Pharmacogenet Genomics. 2022 Apr 1;32(3):79-86. doi: 10.1097/FPC.0000000000000455.
Truong TM, Apfelbaum J, Shahul S, Anitescu M, Danahey K, Knoebel RW, Liebovitz D, Karrison T, van Wijk XMR, Yeo KJ, Meltzer D, Ratain MJ, O'Donnell PH. The ImPreSS Trial: Implementation of Point-of-Care Pharmacogenomic Decision Support in Perioperative Care. Clin Pharmacol Ther. 2019 Dec;106(6):1179-1183. doi: 10.1002/cpt.1567. Epub 2019 Aug 21. No abstract available.
Other Identifiers
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IRB17-1422
Identifier Type: -
Identifier Source: org_study_id