Clinical trial NCT02081872: Utility of PharmacoGenomics for Reducing Adverse Drug Effects
Official title: Utility of PharmacoGenomics for Reducing Adverse Drug Effects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Genetics of Drug Metabolism
Keywords: Pharmacogenomics
Target Drug Related Adverse Events (TDAE)
Lead sponsor: Companion Dx Reference Lab, LLC
Sponsor class: INDUSTRY
First posted: 2014-03-07
Enrollment: 279000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects over the age of 18, receiving at least one medication with metabolism known to depend on genetic allelic variation.

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."


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of Meaningful Change in Drug Regimen
timeFrame: 90 Days
Secondary outcomes:
measure: 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
timeFrame: 90 days
measure: 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
timeFrame: 90 days
measure: 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.
timeFrame: 90 Days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Cardiovascular Center
state: Arizona
city: Augusta
country: United States
facility: ARcare
state: Arkansas
city: Arcadia
country: United States
facility: Retina Institute of California
state: California
city: El Cajon
country: United States
facility: John Allen, M.D.
state: California
city: Newark
country: United States
facility: Delaware Electrophysiology & Cardiology
state: Delaware
city: Boca Raton
country: United States
facility: Boca Raton Clinical Research
state: Florida
city: Clearwater
country: United States
facility: St. Francis Sleep, Allergy & Lung Institute
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Lake Clarke Shores
country: United States
facility: Israel Machin M.D., PA
state: Florida
city: Miami Lakes
country: United States
facility: Angel E. Rico, M.D. PA
state: Florida
city: Miami
country: United States
facility: Shaw Research Specialists, Inc.
state: Florida
city: Palm Bay
country: United States
facility: Advanced Behavioral Care, LLC
state: Florida
city: Chicago
country: United States
facility: Diverse Clinical Research Center of Chicago, LLC
state: Illinois
city: Olympia Fields
country: United States
facility: Aida Mihajlovic M.D. Inc.
state: Illinois
city: Covington
country: United States
facility: Northshore Allergy & Immunology, LLC
state: Louisiana
city: Lake Charles
country: United States
facility: Centex Studies Inc
state: Louisiana
city: Elkton
country: United States
facility: B. John Hynes, M.D.
state: Maryland
city: Lincoln
country: United States
facility: Premier Psychiatric Research Institute, LLC
state: Nebraska
city: Millburn
country: United States
facility: Pain Medicine Physicians
state: New Jersey
city: Montville
country: United States
facility: Vanguard Medical Group
state: New Jersey
city: Moorestown
country: United States
facility: Virtua Medical Group, P.A.
state: New Jersey
city: Phillipsburg
country: United States
facility: Coventry Cardiology Associates
state: New Jersey
city: Trenton
country: United States
facility: Pennington Infectious Disease Associates
state: New Jersey
city: Asheboro
country: United States
facility: White Oak Family Physicians, PA
state: North Carolina
city: Asheville
country: United States
facility: Allergy Partners, P.A.
state: North Carolina
city: Hilliard
country: United States
facility: Buckeye Health and Research LLC
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Shaker Heights
country: United States
facility: Family Medicine and Occupational Health, Inc
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital's Network Office of Research and innovation
state: Pennsylvania
city: Dunmore
country: United States
facility: Wound Institute & Research Center
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Foundation for Education and Research
state: Pennsylvania
city: Shippensburg
country: United States
facility: Wellmon Family Practice
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Neurological Associates, LTD.
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Harlingen
country: United States
state: Texas
city: League City
country: United States
facility: South Shore Medical Center
state: Texas
city: McAllen
country: United States
facility: Renaissance Psychiatry
state: Texas
city: Pharr
country: United States
facility: Centex Studies Inc
state: Texas
city: Waco
country: United States
facility: Hillcrest Family Health Center
state: Texas
city: Arlington
country: United States
facility: Millennium Clinical Trials LLC
state: Virginia
city: South Chesterfield
country: United States
facility: Ettrick Health Center, LLC
state: Virginia
Study officials:
References: