Pharmacogenomic Testing Of the Elderly To Reduce Morbidity

NCT ID: NCT02095769

Last Updated: 2015-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

280000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-01-31

Brief Summary

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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."

Detailed Description

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Conditions

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Genetics of Drug Metabolism

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syntactx

NETWORK

Sponsor Role collaborator

General Genetics Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bill Massey, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Core Insitute

Phoenix, Arizona, United States

Site Status RECRUITING

LifeSpan Institute

La Jolla, California, United States

Site Status RECRUITING

The International Heart & Lung Institute Center for Restorative Medicine

Palm Springs, California, United States

Site Status RECRUITING

Research Physicians Network Alliance

Pembroke Pines, Florida, United States

Site Status RECRUITING

Tallahassee Neurological Institute

Tallahassee, Florida, United States

Site Status RECRUITING

Hypertension Institute

Nashville, Tennessee, United States

Site Status RECRUITING

Diagnostic Clinic of Houston

Houston, Texas, United States

Site Status RECRUITING

Research & Cardiovascular Corp.

Ponce, PR, Puerto Rico

Site Status RECRUITING

Countries

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United States Puerto Rico

Facility Contacts

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Eric Feldman, MD

Role: primary

623-537-5695

Steven A Brody, M.D., Ph.D.

Role: primary

858-344-5020

Steven Gundry, MD

Role: primary

760-323-5553

Perry Krichmar, MD

Role: primary

954-237-6286

Lutheria Hollis

Role: primary

850-877-5115

Mark Houston, MD

Role: primary

615-512-1481

Freemu Varghese, MD

Role: primary

Jose Vazquez Tanus, MD

Role: primary

787-290-8585

Other Identifiers

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201301

Identifier Type: -

Identifier Source: org_study_id

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