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Trial record 32 of 1108 for:    pharmacogenomics OR pharmacogenetics

Utility of PharmacoGenomics for Reducing Adverse Drug Effects (UPGRADE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02081872
Recruitment Status : Unknown
Verified September 2015 by Companion Dx Reference Lab, LLC.
Recruitment status was:  Recruiting
First Posted : March 7, 2014
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Companion Dx Reference Lab, LLC

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."


Condition or disease
Genetics of Drug Metabolism

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 279000 participants
Observational Model: Cohort
Target Follow-Up Duration: 90 Days
Official Title: Utility of PharmacoGenomics for Reducing Adverse Drug Effects
Study Start Date : April 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions




Primary Outcome Measures :
  1. Occurrence of Meaningful Change in Drug Regimen [ Time Frame: 90 Days ]

    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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 90 days ]
  2. 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 [ Time Frame: 90 days ]
  3. 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. [ Time Frame: 90 Days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081872


Contacts
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Contact: Study Coordinator upgrade@companiondxlab.com

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Locations
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United States, Arizona
Scottsdale Cardiovascular Center Recruiting
Scottsdale, Arizona, United States, 85251
Contact: Krishnaswami Vijayaraghaven, M.D.    480-945-3535      
United States, Arkansas
ARcare Recruiting
Augusta, Arkansas, United States, 72006
Contact: Jaime Whitehead, FNP-BC    870-347-3402      
United States, California
Retina Institute of California Recruiting
Arcadia, California, United States, 91007
Contact: Michael Samuel, MD    626-574-0188      
John Allen, M.D. Recruiting
El Cajon, California, United States, 92020
Contact: John W. Allen, M.D.    619-993-3835      
United States, Delaware
Delaware Electrophysiology & Cardiology Recruiting
Newark, Delaware, United States, 19711
Contact: Joseph C Pennington, MD    302-762-3585      
United States, Florida
Boca Raton Clinical Research Recruiting
Boca Raton, Florida, United States, 33432
Contact: Gina Vendetti, MD    561-447-0614      
St. Francis Sleep, Allergy & Lung Institute Recruiting
Clearwater, Florida, United States, 33765
Contact: Francis Averill, M.D.    727-447-3000      
First Coast Cardiovascular Institute Recruiting
Jacksonville, Florida, United States, 32216
Contact: Khalil Afsh, M.D.    904-493-3333      
Israel Machin M.D., PA Recruiting
Lake Clarke Shores, Florida, United States, 33406
Contact: Israel Machin, M.D.    561-290-5607      
Angel E. Rico, M.D. PA Recruiting
Miami Lakes, Florida, United States, 33014
Contact: Angel E Rico, M.D.    305-495-3192      
Shaw Research Specialists, Inc. Recruiting
Miami, Florida, United States, 33137
Contact: Andrew Basile, DO    305-526-5505      
Advanced Behavioral Care, LLC Recruiting
Palm Bay, Florida, United States, 32905
Contact: Richard Bunt, M.D.    321-622-3222      
United States, Illinois
Diverse Clinical Research Center of Chicago, LLC Recruiting
Chicago, Illinois, United States, 60611
Contact: Thomas L Pitts, M.D.    312-763-2211      
Aida Mihajlovic M.D. Inc. Recruiting
Olympia Fields, Illinois, United States, 60461
Contact: Aida Mihajlovic, M.D.    708-481-8290      
United States, Louisiana
Northshore Allergy & Immunology, LLC Recruiting
Covington, Louisiana, United States, 70433
Contact: Richard J. Guillot, M.D.    985-892-3122      
Centex Studies Inc Recruiting
Lake Charles, Louisiana, United States, 70601
Contact: Michael Seep, MD    337-292-0885      
United States, Maryland
B. John Hynes, M.D. Completed
Elkton, Maryland, United States, 21921
United States, Nebraska
Premier Psychiatric Research Institute, LLC Recruiting
Lincoln, Nebraska, United States, 68526
Contact: Walter Duffy, MD    402-817-2235      
United States, New Jersey
Pain Medicine Physicians Recruiting
Millburn, New Jersey, United States, 07041
Contact: Giovanni Ramundo, MD    973-467-1466      
Vanguard Medical Group Recruiting
Montville, New Jersey, United States, 07045
Contact: Andrew Gilmartin, MD    973-575-5540      
Virtua Medical Group, P.A. Recruiting
Moorestown, New Jersey, United States, 08057
Contact: Thomas Galski, D.O.    856-786-7144      
Coventry Cardiology Associates Recruiting
Phillipsburg, New Jersey, United States, 08865
Contact: Daniel Mascarenhas, M.D.    908-859-3800      
Pennington Infectious Disease Associates Recruiting
Trenton, New Jersey, United States, 08638
Contact: Marc S Whitman, MD    609-815-7773      
United States, North Carolina
White Oak Family Physicians, PA Recruiting
Asheboro, North Carolina, United States, 27203
Contact: Robert Scott, M.D.    336-625-1360      
Allergy Partners, P.A. Recruiting
Asheville, North Carolina, United States, 28803
Contact: Frank J Lichtenberger, MD    704-873-5055      
United States, Ohio
Buckeye Health and Research LLC Recruiting
Hilliard, Ohio, United States, 43026
Contact: Robert Florea, M.D.    614-850-7450      
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Contact: Franklin Handel, M.D.    937-643-9939      
Family Medicine and Occupational Health, Inc Recruiting
Shaker Heights, Ohio, United States, 44120
Contact: Elizabeth Ranasinghe, MD    216-295-8400      
United States, Pennsylvania
Lehigh Valley Hospital's Network Office of Research and innovation Recruiting
Allentown, Pennsylvania, United States, 18101
Contact: John A Mannisi    484-884-4799      
Wound Institute & Research Center Recruiting
Dunmore, Pennsylvania, United States, 18512
Contact: Michael Moore, M.D.    570-961-8000      
Guthrie Foundation for Education and Research Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Megha Manek, MD    570-887-2239      
Wellmon Family Practice Recruiting
Shippensburg, Pennsylvania, United States, 17257
Contact: Baxter D Wellmon, DO    717-532-3211      
Abington Neurological Associates, LTD. Recruiting
Willow Grove, Pennsylvania, United States, 19090
Contact: David Weisman, M.D.    215-957-9250      
United States, Texas
Recruiting
Austin, Texas, United States, 78735
Contact: Michael Rotman, MD    512-328-4253      
Withdrawn
Harlingen, Texas, United States, 78550
South Shore Medical Center Recruiting
League City, Texas, United States, 77573
Contact: Jack Janoe, MD    281-334-2826      
Renaissance Psychiatry Recruiting
McAllen, Texas, United States, 78501
Contact: Jose Igoa, M.D.    956-682-4401      
Centex Studies Inc Recruiting
Pharr, Texas, United States, 78577
Contact: Hiram Garcia, MD    956-342-2626      
Hillcrest Family Health Center Recruiting
Waco, Texas, United States, 76710
Contact: Allison Crawford, M.D.    254-202-3825      
United States, Virginia
Millennium Clinical Trials LLC Recruiting
Arlington, Virginia, United States, 22203
Contact: Maria B Natividad, MD    703-527-8100      
Ettrick Health Center, LLC Recruiting
South Chesterfield, Virginia, United States, 23803
Contact: Loknath Shandilya, M.D.    804-526-3500      
Sponsors and Collaborators
Companion Dx Reference Lab, LLC

Additional Information:

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Responsible Party: Companion Dx Reference Lab, LLC
ClinicalTrials.gov Identifier: NCT02081872     History of Changes
Other Study ID Numbers: 2013-101
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: September 2015
Keywords provided by Companion Dx Reference Lab, LLC:
Pharmacogenomics
Target Drug Related Adverse Events (TDAE)
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders