Genetics of Drug MetabolismUPGRADENCT02081872
Utility of PharmacoGenomics for Reducing Adverse Drug Effects
An observational study of Genetics of Drug Metabolism, run by Companion Dx Reference Lab, LLC at 41 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genetics of Drug Metabolism
- How many people
- 279,000 participants
- Where
- 41 sitesUnited States
- Study dates
- Apr 2014to Jul 2017
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
41 sites in 1 country.
Study Coordinator contact
41 sites in 1 country
United States41 sites, 39 recruiting
- Recruiting
Lehigh Valley Hospital's Network Office of Research and innovation
Allentown, Pennsylvania, 18101
John A Mannisi, 484-884-4799
- Recruiting
Retina Institute of California
Arcadia, California, 91007
Michael Samuel, MD, 626-574-0188
- Recruiting
Millennium Clinical Trials LLC
Arlington, Virginia, 22203
Maria B Natividad, MD, 703-527-8100
- Recruiting
White Oak Family Physicians, PA
Asheboro, North Carolina, 27203
Robert Scott, M.D., 336-625-1360
- Recruiting
Allergy Partners, P.A.
Asheville, North Carolina, 28803
Frank J Lichtenberger, MD, 704-873-5055
- Recruiting
ARcare
Augusta, Arkansas, 72006
Jaime Whitehead, FNP-BC, 870-347-3402
- Recruiting
Study site
Austin, Texas, 78735
Michael Rotman, MD, 512-328-4253
- Recruiting
Boca Raton Clinical Research
Boca Raton, Florida, 33432
Gina Vendetti, MD, 561-447-0614
- Recruiting
Diverse Clinical Research Center of Chicago, LLC
Chicago, Illinois, 60611
Thomas L Pitts, M.D., 312-763-2211
- Recruiting
St. Francis Sleep, Allergy & Lung Institute
Clearwater, Florida, 33765
Francis Averill, M.D., 727-447-3000
- Recruiting
Northshore Allergy & Immunology, LLC
Covington, Louisiana, 70433
Richard J. Guillot, M.D., 985-892-3122
- Recruiting
Wound Institute & Research Center
Dunmore, Pennsylvania, 18512
Michael Moore, M.D., 570-961-8000
- Recruiting
John Allen, M.D.
El Cajon, California, 92020
John W. Allen, M.D., 619-993-3835
- Completed
B. John Hynes, M.D.
Elkton, Maryland, 21921
- Withdrawn
Study site
Harlingen, Texas, 78550
- Recruiting
Buckeye Health and Research LLC
Hilliard, Ohio, 43026
Robert Florea, M.D., 614-850-7450
- Recruiting
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216
Khalil Afsh, M.D., 904-493-3333
- Recruiting
Kettering Medical Center
Kettering, Ohio, 45429
Franklin Handel, M.D., 937-643-9939
- Recruiting
Centex Studies Inc
Lake Charles, Louisiana, 70601
Michael Seep, MD, 337-292-0885
- Recruiting
Israel Machin M.D., PA
Lake Clarke Shores, Florida, 33406
Israel Machin, M.D., 561-290-5607
- Recruiting
South Shore Medical Center
League City, Texas, 77573
Jack Janoe, MD, 281-334-2826
- Recruiting
Premier Psychiatric Research Institute, LLC
Lincoln, Nebraska, 68526
Walter Duffy, MD, 402-817-2235
- Recruiting
Renaissance Psychiatry
McAllen, Texas, 78501
Jose Igoa, M.D., 956-682-4401
- Recruiting
Shaw Research Specialists, Inc.
Miami, Florida, 33137
Andrew Basile, DO, 305-526-5505
- Recruiting
Angel E. Rico, M.D. PA
Miami Lakes, Florida, 33014
Angel E Rico, M.D., 305-495-3192
- Recruiting
Pain Medicine Physicians
Millburn, New Jersey, 07041
Giovanni Ramundo, MD, 973-467-1466
- Recruiting
Vanguard Medical Group
Montville, New Jersey, 07045
Andrew Gilmartin, MD, 973-575-5540
- Recruiting
Virtua Medical Group, P.A.
Moorestown, New Jersey, 08057
Thomas Galski, D.O., 856-786-7144
- Recruiting
Delaware Electrophysiology & Cardiology
Newark, Delaware, 19711
Joseph C Pennington, MD, 302-762-3585
- Recruiting
Aida Mihajlovic M.D. Inc.
Olympia Fields, Illinois, 60461
Aida Mihajlovic, M.D., 708-481-8290
- Recruiting
Advanced Behavioral Care, LLC
Palm Bay, Florida, 32905
Richard Bunt, M.D., 321-622-3222
- Recruiting
Centex Studies Inc
Pharr, Texas, 78577
Hiram Garcia, MD, 956-342-2626
- Recruiting
Coventry Cardiology Associates
Phillipsburg, New Jersey, 08865
Daniel Mascarenhas, M.D., 908-859-3800
- Recruiting
Guthrie Foundation for Education and Research
Sayre, Pennsylvania, 18840
Megha Manek, MD, 570-887-2239
- Recruiting
Scottsdale Cardiovascular Center
Scottsdale, Arizona, 85251
Krishnaswami Vijayaraghaven, M.D., 480-945-3535
- Recruiting
Family Medicine and Occupational Health, Inc
Shaker Heights, Ohio, 44120
Elizabeth Ranasinghe, MD, 216-295-8400
- Recruiting
Wellmon Family Practice
Shippensburg, Pennsylvania, 17257
Baxter D Wellmon, DO, 717-532-3211
- Recruiting
Ettrick Health Center, LLC
South Chesterfield, Virginia, 23803
Loknath Shandilya, M.D., 804-526-3500
- Recruiting
Pennington Infectious Disease Associates
Trenton, New Jersey, 08638
Marc S Whitman, MD, 609-815-7773
- Recruiting
Hillcrest Family Health Center
Waco, Texas, 76710
Allison Crawford, M.D., 254-202-3825
- Recruiting
Abington Neurological Associates, LTD.
Willow Grove, Pennsylvania, 19090
David Weisman, M.D., 215-957-9250
About this study
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetics of Drug MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 279,000 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Companion Dx Reference Lab, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081872
- Sponsor's protocol ID
- 2013-101
- Acronym
- UPGRADE
- Status last verified
- Sep 2015
- First submitted
- 4 Mar 2014
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of PharmacoGenomics for Reducing Adverse Drug Effects
- ClinicalTrials.gov ID
- NCT02081872
- Acronym / sponsor ID
- UPGRADE / 2013-101
- Conditions
- Genetics of Drug Metabolism
- Keywords
- Pharmacogenomics, Target Drug Related Adverse Events (TDAE)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 279,000 participants (estimated)
- Lead sponsor
- Companion Dx Reference Lab, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Observational model
- Cohort
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Coordinator contact
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetics of Drug Metabolism, run by Companion Dx Reference Lab, LLC at 41 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (upgrade@companiondxlab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Meaningful Change in Drug Regimen (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.