Utility of PharmacoGenomics for Reducing Adverse Drug Effects

NCT02081872 | Unknown

• 1 other identifier: 2013-101
• Study Type: observational
• Target: 279,000
• Locations: 1 country
• Sites: 41

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."

Conditions

Genetics of Drug Metabolism

Keywords

Pharmacogenomics; Target Drug Related Adverse Events (TDAE)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Companion Dx Reference Lab, LLC: lead

Study Sites (41)

Scottsdale Cardiovascular Center

Scottsdale, Arizona, 85251, United States

RECRUITING

ARcare

Augusta, Arkansas, 72006, United States

RECRUITING

Retina Institute of California

Arcadia, California, 91007, United States

RECRUITING

John Allen, M.D.

El Cajon, California, 92020, United States

RECRUITING

Delaware Electrophysiology & Cardiology

Newark, Delaware, 19711, United States

RECRUITING

Boca Raton Clinical Research

Boca Raton, Florida, 33432, United States

RECRUITING

St. Francis Sleep, Allergy & Lung Institute

Clearwater, Florida, 33765, United States

RECRUITING

First Coast Cardiovascular Institute

Jacksonville, Florida, 32216, United States

RECRUITING

Israel Machin M.D., PA

Lake Clarke Shores, Florida, 33406, United States

RECRUITING

Shaw Research Specialists, Inc.

Miami, Florida, 33137, United States

RECRUITING

Angel E. Rico, M.D. PA

Miami Lakes, Florida, 33014, United States

RECRUITING

Advanced Behavioral Care, LLC

Palm Bay, Florida, 32905, United States

RECRUITING

Diverse Clinical Research Center of Chicago, LLC

Chicago, Illinois, 60611, United States

RECRUITING

Aida Mihajlovic M.D. Inc.

Olympia Fields, Illinois, 60461, United States

RECRUITING

Northshore Allergy & Immunology, LLC

Covington, Louisiana, 70433, United States

RECRUITING

Centex Studies Inc

Lake Charles, Louisiana, 70601, United States

RECRUITING

B. John Hynes, M.D.

Elkton, Maryland, 21921, United States

COMPLETED

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, 68526, United States

RECRUITING

Pain Medicine Physicians

Millburn, New Jersey, 07041, United States

RECRUITING

Vanguard Medical Group

Montville, New Jersey, 07045, United States

RECRUITING

Virtua Medical Group, P.A.

Moorestown, New Jersey, 08057, United States

RECRUITING

Coventry Cardiology Associates

Phillipsburg, New Jersey, 08865, United States

RECRUITING

Pennington Infectious Disease Associates

Trenton, New Jersey, 08638, United States

RECRUITING

White Oak Family Physicians, PA

Asheboro, North Carolina, 27203, United States

RECRUITING

Allergy Partners, P.A.

Asheville, North Carolina, 28803, United States

RECRUITING

Buckeye Health and Research LLC

Hilliard, Ohio, 43026, United States

RECRUITING

Kettering Medical Center

Kettering, Ohio, 45429, United States

RECRUITING

Family Medicine and Occupational Health, Inc

Shaker Heights, Ohio, 44120, United States

RECRUITING

Lehigh Valley Hospital's Network Office of Research and innovation

Allentown, Pennsylvania, 18101, United States

RECRUITING

Wound Institute & Research Center

Dunmore, Pennsylvania, 18512, United States

RECRUITING

Guthrie Foundation for Education and Research

Sayre, Pennsylvania, 18840, United States

RECRUITING

Wellmon Family Practice

Shippensburg, Pennsylvania, 17257, United States

RECRUITING

Abington Neurological Associates, LTD.

Willow Grove, Pennsylvania, 19090, United States

RECRUITING

Unknown Facility

Austin, Texas, 78735, United States

RECRUITING

Unknown Facility

Harlingen, Texas, 78550, United States

WITHDRAWN

South Shore Medical Center

League City, Texas, 77573, United States

RECRUITING

Renaissance Psychiatry

McAllen, Texas, 78501, United States

RECRUITING

Centex Studies Inc

Pharr, Texas, 78577, United States

RECRUITING

Hillcrest Family Health Center

Waco, Texas, 76710, United States

RECRUITING

Millennium Clinical Trials LLC

Arlington, Virginia, 22203, United States

RECRUITING

Ettrick Health Center, LLC

South Chesterfield, Virginia, 23803, United States

RECRUITING

Central Study Contacts

Study Coordinator

CONTACT

upgrade@companiondxlab.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 7, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 8, 2015

Record last verified: 2015-09

Locations

US (41)