Utility of PharmacoGenomics for Reducing Adverse Drug Effects
- Conditions
- Genetics of Drug Metabolism
- Registration Number
- NCT02081872
- Lead Sponsor
- Companion Dx Reference Lab, LLC
- Brief Summary
UPGRADE aims to see whether data from Pharmacogenomic Testing (PGx) can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug reactions, hospitalizations and emergency department visits.
The way an individual processes a drug is in part determined by their genes, and there is known to be genetic variation between humans in the way drugs are metabolized. The study of the way genes affect a person's response to drugs is known as "Pharmacogenomics."
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 279000
- Subject plans to undergo current index PGx testing at the time of enrollment or underwent current index PGx testing within the prior 1-year period, for genes known to influence metabolism of at least one target drug
- Subject is aged ≥18 years
- Subject is able and willing to provide written informed consent
- Subject reveals a history of at least one TDAE or an inadequate therapeutic effect from a target drug over the 12-month period preceding expected receipt of PGx test results
- Subject is not taking an investigational medication or in an interventional trial that would interfere with participation in the registry
- Subject is currently hospitalized
- Subject's medical and medication history is unavailable over the 90-day periods preceding and following the receipt of pharmacogenomic test results
- Subject is unable to provide an accurate history due to mental incapacity
- Subject is known to have undergone prior pharmacogenomic testing (exclusive of the current index PGx testing) for genes specific to the target drugs within the 2-year period preceding enrollment and these results have been previously evaluated
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence of Meaningful Change in Drug Regimen 90 Days The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined for each subject as:
* A genotype known to affect a target drug is identified by PGx testing, AND
* The treating physician makes at least one target drug regimen change in dose, frequency, or route of administration, or when target drug discontinuation or substitutions occur.
- Secondary Outcome Measures
Name Time Method Changes in target drug regimen over the 90-day period preceding receipt of PGx results, compared to the changes made in the 90-day period thereafter 90 days Number of Target Drug-Related Adverse events (TDAE) over the 90-day period preceding receipt of PGx test results compared with the number over the 90-day period after the test 90 days Target-drug related outpatient clinic visits, emergency department visits, and hospitalizations over the 90-day period prior to the receipt of PGx test results, compared to the number of visits over the 90-day period following testing. 90 Days
Trial Locations
- Locations (38)
Angel E. Rico, M.D. PA
🇺🇸Miami Lakes, Florida, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Guthrie Foundation for Education and Research
🇺🇸Sayre, Pennsylvania, United States
Scottsdale Cardiovascular Center
🇺🇸Scottsdale, Arizona, United States
ARcare
🇺🇸Augusta, Arkansas, United States
John Allen, M.D.
🇺🇸El Cajon, California, United States
Retina Institute of California
🇺🇸Arcadia, California, United States
First Coast Cardiovascular Institute
🇺🇸Jacksonville, Florida, United States
Delaware Electrophysiology & Cardiology
🇺🇸Newark, Delaware, United States
Israel Machin M.D., PA
🇺🇸Lake Clarke Shores, Florida, United States
Boca Raton Clinical Research
🇺🇸Boca Raton, Florida, United States
St. Francis Sleep, Allergy & Lung Institute
🇺🇸Clearwater, Florida, United States
Advanced Behavioral Care, LLC
🇺🇸Palm Bay, Florida, United States
Diverse Clinical Research Center of Chicago, LLC
🇺🇸Chicago, Illinois, United States
Aida Mihajlovic M.D. Inc.
🇺🇸Olympia Fields, Illinois, United States
Northshore Allergy & Immunology, LLC
🇺🇸Covington, Louisiana, United States
Centex Studies Inc
🇺🇸Pharr, Texas, United States
B. John Hynes, M.D.
🇺🇸Elkton, Maryland, United States
Premier Psychiatric Research Institute, LLC
🇺🇸Lincoln, Nebraska, United States
Pain Medicine Physicians
🇺🇸Millburn, New Jersey, United States
Vanguard Medical Group
🇺🇸Montville, New Jersey, United States
Coventry Cardiology Associates
🇺🇸Phillipsburg, New Jersey, United States
Virtua Medical Group, P.A.
🇺🇸Moorestown, New Jersey, United States
Pennington Infectious Disease Associates
🇺🇸Trenton, New Jersey, United States
White Oak Family Physicians, PA
🇺🇸Asheboro, North Carolina, United States
Allergy Partners, P.A.
🇺🇸Asheville, North Carolina, United States
Buckeye Health and Research LLC
🇺🇸Hilliard, Ohio, United States
Family Medicine and Occupational Health, Inc
🇺🇸Shaker Heights, Ohio, United States
Lehigh Valley Hospital's Network Office of Research and innovation
🇺🇸Allentown, Pennsylvania, United States
Wound Institute & Research Center
🇺🇸Dunmore, Pennsylvania, United States
Wellmon Family Practice
🇺🇸Shippensburg, Pennsylvania, United States
Abington Neurological Associates, LTD.
🇺🇸Willow Grove, Pennsylvania, United States
South Shore Medical Center
🇺🇸League City, Texas, United States
Renaissance Psychiatry
🇺🇸McAllen, Texas, United States
Hillcrest Family Health Center
🇺🇸Waco, Texas, United States
Millennium Clinical Trials LLC
🇺🇸Arlington, Virginia, United States
Ettrick Health Center, LLC
🇺🇸South Chesterfield, Virginia, United States
Shaw Research Specialists, Inc.
🇺🇸Miami, Florida, United States