Drug Side EffectsPREACTNCT02374840
Pharmacogenomics Registry to Assess Clinical Utility
An observational study of Drug Side Effects, run by Companion Dx Reference Lab, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Drug Side Effects
- How many people
- 340,778 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Feb 2019
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Study Coordinator contact
About this study
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."
- Conditions
- Drug Side Effects
- Keywords
- Pharmacogenomics, Adverse Drug Reactions, Pharmacogenetics
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What is being measured
The primary outcome is the main question the study is designed to answer.
Meaningful Change
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.
Measured: 90 day
Secondary outcomes (4)
Changes in target drug regimen
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 retrospective; 90 days prospective
Number of target drug adverse events (TDAE)
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
Measured: 90 day retrospective; 90 day prospective
Target drug related emergency department visits
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.
Measured: 90 day retrospective; 90 day prospective
Target drug related hospitalizations
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.
Measured: 90 day retrospective; 90 day prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Primary completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Side EffectsStudies 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
- 340,778 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
- NCT02374840
- Sponsor's protocol ID
- CD-2014-102
- Acronym
- PREACT
- Status last verified
- Jul 2015
- First submitted
- 24 Feb 2015
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics Registry to Assess Clinical Utility
- ClinicalTrials.gov ID
- NCT02374840
- Acronym / sponsor ID
- PREACT / CD-2014-102
- Conditions
- Drug Side Effects
- Keywords
- Pharmacogenomics, Adverse Drug Reactions, Pharmacogenetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340,778 participants (estimated)
- Lead sponsor
- Companion Dx Reference Lab, LLCIndustry (pharma, biotech, devices)
- Primary completion
- Feb 2019 (estimated)
- First posted
- 2 Mar 2015 (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.
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 design
- Observational model
- Cohort
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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
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.
4 secondary outcomes
Changes in target drug regimen
Time frame: 90 days retrospective; 90 days prospective
Number of target drug adverse events (TDAE)
Time frame: 90 day retrospective; 90 day prospective
Target drug related emergency department visits
Time frame: 90 day retrospective; 90 day prospective
Target drug related hospitalizations
Time frame: 90 day retrospective; 90 day prospective
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 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
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Side Effects, run by Companion Dx Reference Lab, LLC.
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 3 inclusion and 2 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 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 (preact@companiondxlab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meaningful Change (time frame: 90 day). 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 22 Jul 2015.