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Trial Title:
Informing Pain Treatment Using Pharmacogenomic Analysis
NCT ID:
NCT06511401
Condition:
Analgesia
Cancer
CYP2D6
Conditions: Keywords:
Pharmacogenomic
Opioids
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Pharmacogenomic (PGx) results.
Description:
These results are designed to provide specific dosing information based on the
participant's unique genetics/genomics.
Arm group label:
PGx Arm
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.
Criteria for 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 are enrolled in other Pharmacogenomic (PGx) studies
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Chicago Medicine Comprehensive Cancer Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Intake
Phone:
855-702-8222
Email:
cancerclinicaltrials@bsd.uchicago.edu
Investigator:
Last name:
Peter O'Donnell
Email:
Principal Investigator
Start date:
July 10, 2024
Completion date:
August 2028
Lead sponsor:
Agency:
University of Chicago
Agency class:
Other
Collaborator:
Agency:
National Human Genome Research Institute (NHGRI)
Agency class:
NIH
Source:
University of Chicago
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06511401
