Utility of PharmacoGenomics for Reducing Adverse Drug Effects

Genetics of Drug Metabolism Clinical Trial

— UPGRADE  

Official title:

Utility of PharmacoGenomics for Reducing Adverse Drug Effects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02081872
• Other study ID #: 2013-101
• Status: Recruiting
• Phase: N/A
• First received: March 4, 2014
• Last updated: October 7, 2015
• Start date: April 2014
• Est. completion date: July 2017

Study information

• Verified date: September 2015
• Source: Companion Dx Reference Lab, LLC
• Contact: Study Coordinator
• Email: upgrade[@]companiondxlab.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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."

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 279000
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Genetics of Drug Metabolism

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Companion Dx Reference Lab, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Meaningful Change in Drug Regimen	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.	90 Days	No
Secondary	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	No
Secondary	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	No
Secondary	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	No