NCT06511401 · University of Chicago
Informing Pain Treatment Using Pharmacogenomic Analysis
(C-PAIN)
What this study is about
This is a randomly assigned, forward-looking study to evaluate the effects of preemptive pharmacogenomic (PGx) testing on opioid dosing decisions/selections and pain score in cancer patients.
View original scientific description
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.
Interventions
OTHER
Pharmacogenomic (PGx) results.
These results are designed to provide specific dosing information based on the participant's unique genetics/genomics.
Primary outcome measures
Pain control.
Time frame: 45 days
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Chicago, Illinois
Collaborators
National Human Genome Research Institute (NHGRI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations