NCT06511401

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jul 2024Mar 2028

First Submitted

Initial submission to the registry

July 5, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

July 30, 2024

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

July 5, 2024

Last Update Submit

April 28, 2026

Conditions

Adult Patients Who Are Receiving Oncologic Care

Keywords

PharmacogenomicOpioids

Outcome Measures

Primary Outcomes (1)

  • Pain control.

    Measuring changes in composite pain intensity rating via the numeric rating scale: * Brief Pain Inventory-Short Form (BPI-SF) * Score range: 0 (no pain) to 10 (most pain) * Composite pain intensity score (mean of worst, least, average, and current pain) From baseline to day 45 in patients receiving an index opioid prescription for codeine, tramadol, or hydrocodone.

    45 days

Secondary Outcomes (4)

  • Pain Medication Regimen Changes

    45 days

  • Hospitalization or Emergency Visit for Pain Control

    45 days

  • Cumulative Morphine Equivalents Required

    45 days

  • Type of First Opioid Prescribed

    From enrollment until study end (up to 5 years)

Study Arms (2)

PGx Arm

EXPERIMENTAL

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

Other: Pharmacogenomic (PGx) results.

Control Arm

NO INTERVENTION

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

Interventions

Pharmacogenomic (PGx) results.OTHER

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

PGx Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Interventions

Pharmacogenomic Testing

Intervention Hierarchy (Ancestors)

Genetic TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Peter H O'Donnell

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Intake

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2024

First Posted

July 22, 2024

Study Start

July 30, 2024

Primary Completion (Estimated)

January 7, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)