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Trial record 16 of 1104 for:    pharmacogenomics OR pharmacogenetics

Pharmacogenomics Registry to Assess Clinical Utility (PREACT)

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ClinicalTrials.gov Identifier: NCT02374840
Recruitment Status : Unknown
Verified July 2015 by Companion Dx Reference Lab, LLC.
Recruitment status was:  Not yet recruiting
First Posted : March 2, 2015
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):
Companion Dx Reference Lab, LLC

Brief Summary:

The PREACT Registry aims to see whether data from Pharmacogenomic Testing (PGx) can help healthcare providers manage patient medication regimens and assess if the testing has an effect on reducing medication side effects, 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
Drug Side Effects

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 340778 participants
Observational Model: Cohort
Target Follow-Up Duration: 90 Days
Official Title: Pharmacogenomics Registry to Assess Clinical Utility
Estimated Primary Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions




Primary Outcome Measures :
  1. Meaningful Change [ Time Frame: 90 day ]

    Binary occurrence of meaningful change in drug regimen, defined for each subject as:

    • A genotype known to affect a target drug is identified by pharmacogenomic testing, and
    • The treating physician makes at least one target drug regimen change in dose, frequency, route of administration, drug discontinuation, addition or substitution.


Secondary Outcome Measures :
  1. Changes in target drug regimen [ Time Frame: 90 days retrospective; 90 days prospective ]
    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.

  2. Number of target drug adverse events (TDAE) [ Time Frame: 90 day retrospective; 90 day prospective ]
    Number of TDAE over the 90-day period preceding receipt of pharmacogenomics test results compared with the number over the 90-day period after the test

  3. Target drug related emergency department visits [ Time Frame: 90 day retrospective; 90 day prospective ]
    Emergency department visits over the 90-day period prior to receipt of pharmacogenomics test results, compared to the number of visits over the 90-day period following receipt of test results.

  4. Target drug related hospitalizations [ Time Frame: 90 day retrospective; 90 day prospective ]
    Hospitalizations over the 90-day period prior to receipt of pharmacogenomics test results, compared to the number of visits over the 90-day period following receipt of test results.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects aged 2 years and above, currently receiving or under consideration to receive at least one medication known to be metabolized through relevant genetically-modified pathways.
Criteria

Inclusion Criteria:

  • Pharmacogenomic testing has been performed within 12-months prior to eligibility assessment for genes known to influence metabolism of at least one target drug
  • Subject is 2 years of age or older
  • Subject is not taking an investigational medication or in a clinical trial that would interfere with participation in the registry

Exclusion Criteria:

  • Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of pharmacogenomic test results
  • Subject (or subject's parent/guardian) is unable to provide an accurate history due to mental incapacity, in the Investigator's opinion.

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): NCT02374840


Contacts
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Contact: Study Coordinator preact@companiondxlab.com

Sponsors and Collaborators
Companion Dx Reference Lab, LLC

Additional Information:

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Responsible Party: Companion Dx Reference Lab, LLC
ClinicalTrials.gov Identifier: NCT02374840     History of Changes
Other Study ID Numbers: CD-2014-102
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015
Keywords provided by Companion Dx Reference Lab, LLC:
Pharmacogenomics
Adverse Drug Reactions
Pharmacogenetics
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders