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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HG012273-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Human Genome Research Institute (NHGRI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PGx Arm | Experimental | PGX information is provided to clinicals to inform opioid dosing and selection. |
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| Control Arm | No Intervention | No PGX information provided opioid dosing and selection is according to standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacogenomic (PGx) results. | Other | These results are designed to provide specific dosing information based on the participant's unique genetics/genomics. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain control. | Measuring changes in composite pain intensity rating via the numeric rating scale:
From baseline to day 45 in patients receiving an index opioid prescription for codeine, tramadol, or hydrocodone. | 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Medication Regimen Changes | Pain medication regimen changes will be assessed for patients who were taking an opioid metabolized primarily by CYP2D6. Pain medication regimen changes from baseline to day 45. The timing of subsequent changes in pain regimes after initial opioid selection will also be recorded. | 45 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Intake | Contact | 1-855-702-8222 | cancerclinicaltrials@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Peter H O'Donnell | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medicine Comprehensive Cancer Center | Recruiting | Chicago | Illinois | 60637 | United States |
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| ID | Term |
|---|---|
| D000071185 | Pharmacogenomic Testing |
| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Hospitalization or Emergency Visit for Pain Control |
The rates of hospitalization and emergency room visits for pain are examined with the rates of increased utilization of health care resources, such as emergency department visits, hospitalizations, and pain consultations. Rates of hospitalization or emergency room visits from baseline to day 45. |
| 45 days |
| Cumulative Morphine Equivalents Required | Cumulative Morphine Equivalents will be defined as total amount of opioids taken by a patient that is converted into its morphine equivalent. Dose and frequency of each opioid given during 45 days after its index prescription will be considered during calculation to give final values, which will be compared to Cumulative Morphine Equivalents for Control arms treated per standard of care. | 45 days |
| Type of First Opioid Prescribed | From enrollment until study end (up to 5 years) |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |