Informing Pain Treatment Using Pharmacogenomic Analysis
NCT ID: NCT06511401
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
800 participants
INTERVENTIONAL
2024-07-30
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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PGx Arm
PGX information is provided to clinicals to inform opioid dosing and selection.
Pharmacogenomic (PGx) results.
These results are designed to provide specific dosing information based on the participant's unique genetics/genomics.
Control Arm
No PGX information provided opioid dosing and selection is according to standard of care.
No interventions assigned to this group
Interventions
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Pharmacogenomic (PGx) results.
These results are designed to provide specific dosing information based on the participant's unique genetics/genomics.
Eligibility Criteria
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Inclusion Criteria
* Subjects must be at least 18 years of age.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Human Genome Research Institute (NHGRI)
NIH
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Peter H O'Donnell
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB24-0700
Identifier Type: -
Identifier Source: org_study_id
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