Identify Genetic Variations That Affect The Ability of Patients To Metabolize Drugs Through Metabolic Pathways



Status:Recruiting
Conditions:Peripheral Vascular Disease, Endocrine, Endocrine
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2015
End Date:March 2017
Contact:Pamela Nelson, RN, MS, PhD
Email:pjnelson@bracaneco.com
Phone:888-568-4271

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A Clinical Trial to Identify Genetic Variations That Affect The Ability of Patients To Metabolize Drugs Through Metabolic Pathways 2C19, 2C9, 2D6, 3A4, 3A5, Factor II, Factor V, MTHFR and VKORC1

This observation will look at patient care decisions of the primary healthcare provider
utilizing the results of the DNA testing of patients' metabolic pathways using 2C19, 2C9,
2D6, 3A4, Factor II, Factor V and MTHFR and VKORC1. Findings of the data collection will be
published to optimize the benefits of pharmacogenomics testing and publish health outcomes.

This study will analyze de-identified data from patients identified by the primary
healthcare provider where a DNA sample has been collected; the medical history and
medications at the time the DNA sample was collected; the date of the DNA pathway testing
and the results. The study will collect and assess the patient data where the healthcare
provider has explained the results of the DNA testing to the patient and made applicable
changes in the healthcare plan based on the DNA pathway results. Patients will have returned
to the healthcare provider after a minimum of ninety (90) days for follow-up to assess the
outcome of the care plan changes started after the DNA results provided. This study will
collect the healthcare provider will provide the outcomes of the healthcare plan changes.

Inclusion Criteria:

1. Adult male or female patients age 18 or older

2. Prescribed at least one medication with in any of the metabolic pathways being
assessed will be enrolled in the study.

3. Completed DNA testing for the pathways under review for this observation.

Exclusion Criteria:

1. Anticipated life expectancy less than 1 month.

2. Employee of the investigator, with direct involvement in the proposed study or other
studies under the direction of the investigator, as well as immediate family members
or the employee or primary care provider.
We found this trial at
1
site
Sevierville, Tennessee 37862
Phone: 856-774-2292
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mi
from
Sevierville, TN
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