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Informing Pain Treatment Using Pharmacogenomic Analysis (C-PAIN)

The University of Chicago logo

The University of Chicago

Status

Enrolling

Conditions

Adult Patients Who Are Receiving Oncologic Care

Treatments

Other: Pharmacogenomic (PGx) results.

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06511401
IRB24-0700
1R01HG012273-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

800 participants in 2 patient groups

PGx Arm
Experimental group
Description:
PGX information is provided to clinicals to inform opioid dosing and selection.
Treatment:
Other: Pharmacogenomic (PGx) results.
Control Arm
No Intervention group
Description:
No PGX information provided opioid dosing and selection is according to standard of care.

Trial contacts and locations

1

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Central trial contact

Clinical Trials Intake

Data sourced from clinicaltrials.gov

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