Utility of PharmacoGenomics for Reducing Adverse Drug Effects (UPGRADE)

Companion Dx Reference Lab

Status: Unknown

Conditions: Genetics of Drug Metabolism

Study type: Observational

Funder types: Industry

Identifiers

NCT02081872

2013-101

Details and patient eligibility

About

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."

Enrollment: 279,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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