Pharmacogenomic Testing Of the Elderly To Reduce Morbidity

NCT02095769 | Unknown

• 1 other identifier: 201301
• Study Type: observational
• Target: 280,000
• Locations: 2 countries
• Sites: 8

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."

Conditions

Genetics of Drug Metabolism

Keywords

Pharmacogenomics; Adverse Drug Reactions

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  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

  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

  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

  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

  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

  90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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").

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Genetics Corporation: lead
• Syntactx: collaborator

Study Sites (8)

Core Insitute

Phoenix, Arizona, 85023, United States

RECRUITING

LifeSpan Institute

La Jolla, California, 92037, United States

RECRUITING

The International Heart & Lung Institute Center for Restorative Medicine

Palm Springs, California, 92262, United States

RECRUITING

Research Physicians Network Alliance

Pembroke Pines, Florida, 33026, United States

RECRUITING

Tallahassee Neurological Institute

Tallahassee, Florida, 32308, United States

RECRUITING

Hypertension Institute

Nashville, Tennessee, 37205, United States

RECRUITING

Diagnostic Clinic of Houston

Houston, Texas, 77004, United States

RECRUITING

Research & Cardiovascular Corp.

Ponce, PR, 00717, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Bill Massey, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: March 26, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 24, 2015

Record last verified: 2015-02

Locations

US (7); PR (1)