Genetics of Drug MetabolismPOETRYNCT02095769
Pharmacogenomic Testing Of the Elderly To Reduce Morbidity
An observational study of Genetics of Drug Metabolism, run by General Genetics Corporation at 8 sites in 2 countries.
Trial summary
The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug events, 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
- 280,000 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Apr 2014to Jan 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: Subjects aged 65 and above or subjects aged 18 and above who have a disability will be eligible for inclusion in the study if they are receiving or are planned to receive at least one medication with a metabolic pathway linked to genetic variations ("target drug").
Who may be able to join
- Subject underwent PGx testing for the alleles appropriate to the target drugs within the prior 90 days ('index PGx test')
- Males and females aged ≥65 years or male and females aged ≥18 years who have a disability
- Subject is able and willing to provide written informed consent
- Subject was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test, including over-the-counter medications
- Subject has a history of at least one target drug-related adverse event (TDAE) over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug
Who cannot join
- Subject is currently hospitalized
- Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx test results
- Subject is unable to provide an accurate history due to mental incapacity
- Subject is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Registry
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
Diagnostic Clinic of Houston
Houston, Texas, 77004
Freemu Varghese, MD, fvarghese@diagnosticclinic.com
Freemu Varghese, MD
- Recruiting
LifeSpan Institute
La Jolla, California, 92037
Steven A Brody, M.D., Ph.D., 858-344-5020, sbrodymd@lifespan-md.com
Steven A Brody, M.D., Ph.D.
- Recruiting
Hypertension Institute
Nashville, Tennessee, 37205
Mark Houston, MD, 615-512-1481, boohouston@comcast.net
Mark C Houston, M.D.
- Recruiting
The International Heart & Lung Institute Center for Restorative Medicine
Palm Springs, California, 92262
Steven Gundry, MD, 760-323-5553, DocSRG@aol.com
Steven Gundry, MD
- Recruiting
Research Physicians Network Alliance
Pembroke Pines, Florida, 33026
Perry Krichmar, MD, 954-237-6286, pkrichmar@rpna.net
Perry Krichmar, MD
- Recruiting
Core Insitute
Phoenix, Arizona, 85023
Eric Feldman, MD, 623-537-5695, eric.feldman@thecoreinstitute.com
Eric Feldman, MD
- Recruiting
Tallahassee Neurological Institute
Tallahassee, Florida, 32308
Lutheria Hollis, 850-877-5115, lhollis@tnc-neuro.com
Matthew Lawson, MD
Puerto Rico1 site, 1 recruiting
- Recruiting
Research & Cardiovascular Corp.
Ponce, PR, 00717
Jose Vazquez Tanus, MD, 787-290-8585, vazqueztanus@me.com
Jose Vazquez Tanus, MD
About this study
The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug events, hospitalizations, and emergency department visits.
The way an individual processes or metabolizes a drug is in part determined by their genes, and there is known to be genetic variation from one human to another. The study of the way in which genes affect an individual's response to drugs is known as "Pharmacogenomics."
- Conditions
- Genetics of Drug Metabolism
- Keywords
- Pharmacogenomics, Adverse Drug Reactions
- 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.
Occurrence of Meaningful Change in Drug Regimen
The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each subject when:
- A genotype known to affect a drug the subject is taking is identified, and
- The subject's treating physician makes at least one target drug regimen change, dose, substitution, or discontinuation.
Measured: 90 days
Secondary outcomes (8)
Binary occurrence of meaningful change in drug regimen, defined at the drug level over the 90-day period following receipt of PGx test results
Measured: 90 days
Binary occurrence of meaningful change in drug regimen, defined at the gene level over the 90-day period following receipt of PGx test results
Measured: 90 days
Binary occurrence of whether, in the Investigator's opinion, the subject experienced clinical benefit from drug regimen changes made as a result of the PGx test
Clinical benefit refers to improvement in the subject's condition in the Investigator's opinion
Measured: 90 days
Number of changes in a subject's target drugs, tabulated on a per-subject basis by number and percentage of target drugs and total drugs
Measured: 90 days
Binary change (yes/no) in the regimen of drugs controlled by genes of interest over the 90-day period preceding PGx testing compared with the change (yes/no) over the 90-day period following receipt of PGx test results
Measured: 90 days
Number of target drug-related adverse events over the 90-day period prior to and following PGx testing
Measured: 90 days
Emergency department visits over the 90-day periods prior to and following PGx testing
Measured: 90 days
Hospitalizations over the 90-day period prior to and following receipt of PGx test results
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 posted26 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2017 (estimated)
- Study completionJan 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
- 280,000 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- General Genetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Responsible party
- Sponsor
- Investigators
- Bill Massey, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095769
- Sponsor's protocol ID
- 201301
- Acronym
- POETRY
- Status last verified
- Feb 2015
- First submitted
- 19 Mar 2014
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomic Testing Of the Elderly To Reduce Morbidity
- ClinicalTrials.gov ID
- NCT02095769
- Acronym / sponsor ID
- POETRY / 201301
- Conditions
- Genetics of Drug Metabolism
- Keywords
- Pharmacogenomics, Adverse Drug Reactions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280,000 participants (estimated)
- Lead sponsor
- General Genetics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Syntactx
- Study start
- Apr 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 26 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.
The goal of the POETRY Registry is to determine whether data from Pharmacogenomic (PGx) Testing for elderly and disabled patients can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug events, hospitalizations, and emergency department visits.
The way an individual processes or metabolizes a drug is in part determined by their genes, and there is known to be genetic variation from one human to another. The study of the way in which genes affect an individual'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
- Subjects aged 65 and above or subjects aged 18 and above who have a disability will be eligible for inclusion in the study if they are receiving or are planned to receive at least one medication with a metabolic pathway linked to genetic variations ("target drug").
Key inclusion criteria (5 listed)
- Subject underwent PGx testing for the alleles appropriate to the target drugs within the prior 90 days ('index PGx test')
- Males and females aged ≥65 years or male and females aged ≥18 years who have a disability
- Subject is able and willing to provide written informed consent
- Subject was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test, including over-the-counter medications
- Subject has a history of at least one target drug-related adverse event (TDAE) over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug
Key exclusion criteria (4 listed)
- Subject is currently hospitalized
- Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx test results
- Subject is unable to provide an accurate history due to mental incapacity
- Subject is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Registry
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 in each subject when: 1. A genotype known to affect a drug the subject is taking is identified, and 2. The subject's treating physician makes at least one target drug regimen change, dose, substitution, or discontinuation.
8 secondary outcomes
Binary occurrence of meaningful change in drug regimen, defined at the drug level over the 90-day period following receipt of PGx test results
Time frame: 90 days
Binary occurrence of meaningful change in drug regimen, defined at the gene level over the 90-day period following receipt of PGx test results
Time frame: 90 days
Binary occurrence of whether, in the Investigator's opinion, the subject experienced clinical benefit from drug regimen changes made as a result of the PGx test
Time frame: 90 days
Number of changes in a subject's target drugs, tabulated on a per-subject basis by number and percentage of target drugs and total drugs
Time frame: 90 days
Binary change (yes/no) in the regimen of drugs controlled by genes of interest over the 90-day period preceding PGx testing compared with the change (yes/no) over the 90-day period following receipt of PGx test results
Time frame: 90 days
Number of target drug-related adverse events over the 90-day period prior to and following PGx testing
Time frame: 90 days
Emergency department visits over the 90-day periods prior to and following PGx testing
Time frame: 90 days
Hospitalizations over the 90-day period prior to and following receipt of PGx test results
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 24 Feb 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.
The International Heart & Lung Institute Center for Restorative Medicine
Palm Springs, United States
Bill Massey, PhD principal investigator
Northwestern University
8 sites in 2 countries: 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 General Genetics Corporation at 8 sites in 2 countries.
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 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Puerto Rico. 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 24 Feb 2015.