Recruiting

Pharmacogenomic Analysis

Sponsor:

University of Chicago

Code:

NCT06511401

Conditions

Adult Patients Who Are Receiving Oncologic Care

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pharmacogenomic (PGx) results.

Study Details

Brief summary:

This is a randomized, prospective study to evaluate the effects of preemptive pharmacogenomic (PGx) testing on opioid dosing decisions/selections and pain score in cancer patients.

Conditions

Adult Patients Who Are Receiving Oncologic Care

Study ID

NCT06511401

Start date

Jul 30, 2024

Status verified date

Apr, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Jan 7, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Persons receiving ongoing oncology care at the University of Chicago Medical Center for whom near-future pain opioid pain medication therapy is anticipated
  • Subjects must be at least 18 years of age.

Exclusion Criteria:

  • Subjects taking an opioid at the time of enrollment, or within the past 30 days
  • Subjects who are currently undergoing palliative radiation
  • Subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation.
  • Subjects with a history of or active blood cancer (e.g., leukemia).
  • Chronic kidney disease, as defined by Glomerular filtration rate (GFR) < 30/mL/min/1.73m2, due to the risk of decreased drug excretion.
  • Liver dysfunction, as defined by the following laboratory values, due to the risk of decreased drug metabolism: Total bilirubin greater than or equal to1.5 mg/dL, Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) greater than or equal to 2.5 X upper limit of normal\*. (\*Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) \\ greater than or equal to 5 X upper limit of normal if hepatic metastases are present).
  • Inability to understand and give informed consent to participate in the opinion of the investigator
  • Subjects who are known to be pregnant at the time of enrollment
  • Subjects who have previously or are currently enrolled in another institutional pharmacogenomic genotyping study, or are known to have previously undergone pharmacogenomic genotyping for the gene(s) of interest via another commercial or other means.

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: PGx Arm

PGX information is provided to clinicals to inform opioid dosing and selection.

no intervention: Control Arm

No PGX information provided opioid dosing and selection is according to standard of care.

Interventions

Pharmacogenomic (PGx) results.

These results are designed to provide specific dosing information based on the participant's unique genetics/genomics.

Primary outcome measure

  • Pain control. [ Time Frame: 45 days ]

Central Contacts and Locations

Central contacts

Clinical Trials Intake

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

Locations

University of Chicago Medicine Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Clinical Trials Intake

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

Principal Investigator:

Peter O'Donnell

More Information

Sponsor

University of Chicago

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Pharmacogenomic
  • Opioids

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 2026-05-04.