Clinical trial NCT02095769: Pharmacogenomic Testing Of the Elderly To Reduce Morbidity
Official title: Pharmacogenomic Testing Of the Elderly To Reduce Morbidity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Genetics of Drug Metabolism
Keywords: Pharmacogenomics
Adverse Drug Reactions
Lead sponsor: General Genetics Corporation
Sponsor class: INDUSTRY
Collaborators: name: Syntactx
First posted: 2014-03-26
Enrollment: 280000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
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").

Brief 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.

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."


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Occurrence of Meaningful Change in Drug Regimen
timeFrame: 90 days
Secondary outcomes:
measure: Binary occurrence of meaningful change in drug regimen, defined at the drug level over the 90-day period following receipt of PGx test results
timeFrame: 90 days
measure: Binary occurrence of meaningful change in drug regimen, defined at the gene level over the 90-day period following receipt of PGx test results
timeFrame: 90 days
measure: 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
timeFrame: 90 days
measure: 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
timeFrame: 90 days
measure: 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
timeFrame: 90 days
measure: Number of target drug-related adverse events over the 90-day period prior to and following PGx testing
timeFrame: 90 days
measure: Emergency department visits over the 90-day periods prior to and following PGx testing
timeFrame: 90 days
measure: Hospitalizations over the 90-day period prior to and following receipt of PGx test results
timeFrame: 90 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Core Insitute
state: Arizona
city: La Jolla
country: United States
facility: LifeSpan Institute
state: California
city: Palm Springs
country: United States
facility: The International Heart & Lung Institute Center for Restorative Medicine
state: California
city: Pembroke Pines
country: United States
facility: Research Physicians Network Alliance
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Institute
state: Florida
city: Nashville
country: United States
facility: Hypertension Institute
state: Tennessee
city: Houston
country: United States
facility: Diagnostic Clinic of Houston
state: Texas
city: Ponce
country: Puerto Rico
facility: Research & Cardiovascular Corp.
Study officials:
affiliation: Northwestern University
name: Bill Massey, PhD
role: PRINCIPAL_INVESTIGATOR
References: