Pharmacogenomics Registry to Assess Clinical Utility

• Conditions: Drug Side Effects

• Registration Number: NCT02374840
• Lead Sponsor: 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."

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-22
• Primary Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 340778

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Meaningful Change	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

Name	Time	Method
Number of target drug adverse events (TDAE)	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
Target drug related emergency department visits	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.
Target drug related hospitalizations	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.
Changes in target drug regimen	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.