Utility of PharmacoGenomics for Reducing Adverse Drug Effects

Status unconfirmed

Conditions studied: Genetics of Drug Metabolism

In brief

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."

Key facts

Study ID

NCT02081872

Run by

Companion Dx Reference Lab, LLC

People needed

279000

Starts

2014-04-01

Expected to finish

2017-07-01

Last updated by the study team

2015-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ettrick Health Center, LLC — South Chesterfield, Virginia, United States (enrolling)
• ARcare — Augusta, Arkansas, United States (enrolling)
• Retina Institute of California — Arcadia, California, United States (enrolling)
• John Allen, M.D. — El Cajon, California, United States (enrolling)
• Delaware Electrophysiology & Cardiology — Newark, Delaware, United States (enrolling)
• Boca Raton Clinical Research — Boca Raton, Florida, United States (enrolling)
• St. Francis Sleep, Allergy & Lung Institute — Clearwater, Florida, United States (enrolling)
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States (enrolling)
• Israel Machin M.D., PA — Lake Clarke Shores, Florida, United States (enrolling)
• Shaw Research Specialists, Inc. — Miami, Florida, United States (enrolling)
• Angel E. Rico, M.D. PA — Miami Lakes, Florida, United States (enrolling)
• Advanced Behavioral Care, LLC — Palm Bay, Florida, United States (enrolling)
• Diverse Clinical Research Center of Chicago, LLC — Chicago, Illinois, United States (enrolling)
• Aida Mihajlovic M.D. Inc. — Olympia Fields, Illinois, United States (enrolling)
• Northshore Allergy & Immunology, LLC — Covington, Louisiana, United States (enrolling)
• Centex Studies Inc — Lake Charles, Louisiana, United States (enrolling)
• Millennium Clinical Trials LLC — Arlington, Virginia, United States (enrolling)
• Scottsdale Cardiovascular Center — Scottsdale, Arizona, United States (enrolling)
• Premier Psychiatric Research Institute, LLC — Lincoln, Nebraska, United States (enrolling)
• Pain Medicine Physicians — Millburn, New Jersey, United States (enrolling)
• Vanguard Medical Group — Montville, New Jersey, United States (enrolling)
• Virtua Medical Group, P.A. — Moorestown, New Jersey, United States (enrolling)
• Coventry Cardiology Associates — Phillipsburg, New Jersey, United States (enrolling)
• Pennington Infectious Disease Associates — Trenton, New Jersey, United States (enrolling)
• White Oak Family Physicians, PA — Asheboro, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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