Recruiting NCT06511401
Informing Pain Treatment Using Pharmacogenomic Analysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pharmacogenomic (PGx) results..
- Who it may be relevant to
- Registry conditions: Adult Patients Who Are Receiving Oncologic Care. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
C-PAIN: Catalyzing Pharmacogenomic Analysis for Informing Pain Treatment
Overview
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]
Secondary outcome measures (4)
- Pain Medication Regimen Changes [Time frame: 45 days]
- Hospitalization or Emergency Visit for Pain Control [Time frame: 45 days]
- Cumulative Morphine Equivalents Required [Time frame: 45 days]
- Type of First Opioid Prescribed [Time frame: From enrollment until study end (up to 5 years)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Chicago Medicine Comprehensive Cancer Center — Chicago
Identifiers
NCT: NCT06511401 · IRB24-0700 · 1R01HG012273-01A1