RECRUITING

The ImPreSS Trial: Pharmacogenomic Decision Making at Time of Surgery

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2019-01-22
Study Completion:2025-08-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03729180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients who have planned elective surgical procedures at the University of Chicago
  2. * Must be aged 18 years or older
  1. * Patients who have undergone, or are being actively considered for, liver or kidney transplantation
  2. * Patients with known active or prior leukemia.
  3. * Inability to understand and give informed consent to participate.

Contacts and Locations

Study Contact

Cancer Clinical Trials Office
CONTACT
1-855-702-8222
cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator

Peter O'Donnell
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

University Of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Peter O'Donnell, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-22
Study Completion Date2025-08-22

Study Record Updates

Study Start Date2019-01-22
Study Completion Date2025-08-22

Terms related to this study

Additional Relevant MeSH Terms

  • Surgery