Recruiting

Pharmacogenomic Support

Sponsor:

University of Chicago

Code:

NCT03225820

Conditions

Information Seeking Behavior

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

(a) To explore the feasibility and utility of implementing broad preemptive pharmacogenomic result delivery in the inpatient setting across multiple institutions specifically with the goal of incorporating minority-specific pharmacogenomic information; (b) To determine whether clinical outcomes for the drug warfarin are improved in African Americans through the availability of pharmacogenomics-based dosing guidance at the point-of-care.

Conditions

Information Seeking Behavior

Study ID

NCT03225820

Start date

Nov 9, 2017

Status verified date

Apr, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must be at least 18 years of age.
  • Patients must self-identify as African American

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.
  • For patients being recruited to the warfarin sub-study, those with a glomerular filtration rate or creatinine clearance <30 mL/min34.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Overall Pharmacogenomics

All patients who consent to participation will be preemptively genotyped, at no cost to the patient nor provider. A portion of the enrolled patients will be specifically recruited for the usual care arm (no study-specific PGx information available to providers for these patients). Note that patients who are randomized to the Control Arm will be genotyped, but their results will be withheld (not available via GPS) for at least 90 days. For the warfarin sub-study, treating providers caring for patients assigned to both arms are permitted to dose warfarin according to their own discretion and best practices. In either arm of the study, providers may utilize any available other tools or decision-supports for guiding warfarin dosing, including pharmacy assistance.

NOTE: The purpose of the study is to observe if physicians/pharmacists use the genotyped information to determine prescription habits.

Warfarin Sub-Study

All patients who consent to participation will be preemptively genotyped, at no cost to the patient nor provider. A portion of the enrolled patients will be specifically recruited for the warfarin sub-study, in which patients will be randomized in 1:1 fashion to the pharmacogenomics arm of the study. Note that patients who are randomized to the Control Arm will be genotyped, but their results will be withheld (not available via GPS) for at least 90 days. For the warfarin sub-study, treating providers caring for patients assigned to both arms are permitted to dose warfarin according to their own discretion and best practices. In either arm of the study, providers may utilize any available other tools or decision-supports for guiding warfarin dosing, including pharmacy assistance.

NOTE: Warfarin is prescribed as a standard of care drug. The purpose of the study is to observe if physicians/pharmacists use the genotyped information to determine prescription habits.

Primary outcome measure

  • Frequency of Geonomic Prescribing System (GPS) use by physicians and pharmacists [ Time Frame: Up to 5 years ]
  • Number of improved clinical outcomes [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Cancer Clinical Trials Office

1-855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Locations

The University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60607

Contacts

Peter O'Donnell, MD

773-702-7564

More Information

Sponsor

University of Chicago

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • pharmacogenomic information

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-04-24.