Pharmacogenomics Registry to Assess Clinical Utility (PREACT)

July 20, 2015 updated by: Companion Dx Reference Lab, LLC

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."

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

340778

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days retrospective; 90 days prospective
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
90 day retrospective; 90 day prospective
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.
90 day retrospective; 90 day prospective
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.
90 day retrospective; 90 day prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Companion Dx Reference Lab, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

March 2, 2015

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-2014-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Drug Side Effects

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe