NCT03729180 The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery
| NCT ID | NCT03729180 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Chicago |
| Condition | Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,900 participants |
| Start Date | 2019-01-22 |
| Primary Completion | 2027-08-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,900 participants in total. It began in 2019-01-22 with a primary completion date of 2027-08-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Peter O'Donnell
PRINCIPAL INVESTIGATOR
University of Chicago
Frequently Asked Questions
Who can join the NCT03729180 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03729180 currently recruiting?
Yes, NCT03729180 is actively recruiting participants. Contact the research team at cancerclinicaltrials@bsd.uchicago.edu for enrollment information.
Where is the NCT03729180 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT03729180 clinical trial?
NCT03729180 is sponsored by University of Chicago. The principal investigator is Peter O'Donnell at University of Chicago. The trial plans to enroll 1,900 participants.