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Trial record 2 of 12 for:    POETRY

Pharmacogenomic Testing Of the Elderly To Reduce Morbidity (POETRY)

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ClinicalTrials.gov Identifier: NCT02095769
Recruitment Status : Unknown
Verified February 2015 by General Genetics Corporation.
Recruitment status was:  Recruiting
First Posted : March 26, 2014
Last Update Posted : February 24, 2015
Sponsor:
Collaborator:
Syntactx
Information provided by (Responsible Party):
General Genetics Corporation

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."


Condition or disease
Genetics of Drug Metabolism

Study Type : Observational [Patient Registry]
Estimated Enrollment : 280000 participants
Observational Model: Cohort
Target Follow-Up Duration: 90 Days
Official Title: Pharmacogenomic Testing Of the Elderly To Reduce Morbidity
Study Start Date : April 2014
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
    Clinical benefit refers to improvement in the subject's condition in the Investigator's opinion

  4. 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 ]
  5. 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 ]
  6. Number of target drug-related adverse events over the 90-day period prior to and following PGx testing [ Time Frame: 90 days ]
  7. Emergency department visits over the 90-day periods prior to and following PGx testing [ Time Frame: 90 days ]
  8. Hospitalizations over the 90-day period prior to and following receipt of PGx test results [ Time Frame: 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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").
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02095769


Locations
United States, Arizona
Core Insitute Recruiting
Phoenix, Arizona, United States, 85023
Contact: Eric Feldman, MD    623-537-5695    eric.feldman@thecoreinstitute.com   
Principal Investigator: Eric Feldman, MD         
United States, California
LifeSpan Institute Recruiting
La Jolla, California, United States, 92037
Contact: Steven A Brody, M.D., Ph.D.    858-344-5020    sbrodymd@lifespan-md.com   
Principal Investigator: Steven A Brody, M.D., Ph.D.         
The International Heart & Lung Institute Center for Restorative Medicine Recruiting
Palm Springs, California, United States, 92262
Contact: Steven Gundry, MD    760-323-5553    DocSRG@aol.com   
Principal Investigator: Steven Gundry, MD         
United States, Florida
Research Physicians Network Alliance Recruiting
Pembroke Pines, Florida, United States, 33026
Contact: Perry Krichmar, MD    954-237-6286    pkrichmar@rpna.net   
Principal Investigator: Perry Krichmar, MD         
Tallahassee Neurological Institute Recruiting
Tallahassee, Florida, United States, 32308
Contact: Lutheria Hollis    850-877-5115    lhollis@tnc-neuro.com   
Principal Investigator: Matthew Lawson, MD         
United States, Tennessee
Hypertension Institute Recruiting
Nashville, Tennessee, United States, 37205
Contact: Mark Houston, MD    615-512-1481    boohouston@comcast.net   
Principal Investigator: Mark C Houston, M.D.         
United States, Texas
Diagnostic Clinic of Houston Recruiting
Houston, Texas, United States, 77004
Contact: Freemu Varghese, MD       fvarghese@diagnosticclinic.com   
Principal Investigator: Freemu Varghese, MD         
Puerto Rico
Research & Cardiovascular Corp. Recruiting
Ponce, Puerto Rico, 00717
Contact: Jose Vazquez Tanus, MD    787-290-8585    vazqueztanus@me.com   
Principal Investigator: Jose Vazquez Tanus, MD         
Sponsors and Collaborators
General Genetics Corporation
Syntactx
Investigators
Principal Investigator: Bill Massey, PhD Northwestern University

Responsible Party: General Genetics Corporation
ClinicalTrials.gov Identifier: NCT02095769     History of Changes
Other Study ID Numbers: 201301
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015

Keywords provided by General Genetics Corporation:
Pharmacogenomics
Adverse Drug Reactions