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Pharmacogenomics

Genetic Testing for Surgery

N/A

Recruiting

Led By Peter O'Donnell

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be aged 18 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing whether or not giving doctors information about a patient's genetic makeup will help them make better decisions about that patient's care.

Who is the study for?

Adults over 18 years old who are scheduled for elective surgery at the University of Chicago can join. They must be able to understand and agree to participate. People with past or active leukemia, or those considered for liver or kidney transplants cannot join.Check my eligibility

What is being tested?

The trial is testing if using a blood test to check how patients' genes affect their reaction to drugs (pharmacogenomics) before surgery can help doctors choose better medications. Initially, all will get this test, then they'll be randomly split into two groups: one where doctors see these genetics results and one where they don't.See study design

What are the potential side effects?

Since the intervention involves genetic testing and information sharing rather than drug administration, there are no direct side effects from the interventions being studied in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of use of high-risk drugs in perioperative setting

The frequency of Genomic Prescribing System (GPS) use by anesthesiologists and pain medicine physicians and associated providers during the perioperative period.

Secondary outcome measures

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

Comparison of pain scores on a 10 point scale

Differences in patient reported satisfaction using research database

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Pharmacogenomic (PGx) Arm [Randomization Arm 1]Experimental Treatment3 Interventions

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

Group II: Pain CohortExperimental Treatment3 Interventions

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.

Group III: Control Arm [Randomization Arm 2]Experimental Treatment2 Interventions

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,002 Previous Clinical Trials

815,950 Total Patients Enrolled

4 Trials studying Surgery

364 Patients Enrolled for Surgery

Peter O'DonnellPrincipal InvestigatorUniversity of Chicago

1 Previous Clinical Trials

95 Total Patients Enrolled

Media Library

Routine Elective Surgery (Pharmacogenomics) Clinical Trial Eligibility Overview. Trial Name: NCT03729180 — N/A

Surgery Research Study Groups: Control Arm [Randomization Arm 2], Pain Cohort, Pharmacogenomic (PGx) Arm [Randomization Arm 1]

Surgery Clinical Trial 2023: Routine Elective Surgery Highlights & Side Effects. Trial Name: NCT03729180 — N/A

Routine Elective Surgery (Pharmacogenomics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03729180 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are being included in this research project?

"Affirmative. Clinicaltrials.gov records that this research study, which was first unveiled on January 22nd 2019, is actively inviting participants to join its ranks. Approximately 1900 individuals need to be recruited from 1 medical facility."

Answered by AI

Are there any remaining slots available to join this experiment?

"According to the information provided by clinicaltrials.gov, this trial is actively seeking volunteers for enrollment. It was initially posted on January 22nd 2019 and has subsequently been modified as recenty as January 7th 2022."

Answered by AI

What are the key goals of this experiment?

"This investigation, which is projected to last for five years, will study the regularity of Genomic Prescribing System (GPS) use amongst anesthesia and pain medicine physicians. Secondary objectives include ascertaining anesthesiologists' understanding and opinions on prescribing decisions as well as exploring any disparities in patient satisfaction and adherence likelihood between those who received pharmacogenomics information versus those who did not. Additionally, this research seeks to discern how access to genomic results affects the quality of care delivered by pain management services."

Answered by AI

Recent research and studies

Clinical Pharmacology & TherapeuticsJournal

The Impre <scp>ss</scp> Trial: Implementation of Point‐of‐care Pharmacogenomic Decision Support in Perioperative Care

Truong, Tien M., Jeffrey Apfelbaum, Sajid Shahul, Magdalena Anitescu, Keith Danahey, Randall W. Knoebel, David Liebovitz, et al.. 2019. “The Impre ss Trial: Implementation of Point‐of‐care Pharmacogenomic Decision Support in Perioperative Care”. Clinical Pharmacology & Therapeutics. Wiley. doi:10.1002/cpt.1567.

Pharmacogenetics and GenomicsJournal

Anesthesia Providers as Stakeholders to Adoption of Pharmacogenomic Information in Perioperative Care

Truong, Tien M., Jeffrey L. Apfelbaum, Emily Schierer, Keith Danahey, Brittany A. Borden, Theodore Karrison, Sajid Shahul, et al.. 2021. “Anesthesia Providers as Stakeholders to Adoption of Pharmacogenomic Information in Perioperative Care”. Pharmacogenetics and Genomics. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/fpc.0000000000000455.

clinicaltrials.govStudy

The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery

2019. "The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03729180.