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NCT02525887 Clinical Trial

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

Cardiovascular Disease Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02525887
Other study ID # IFG201502-PGX
Secondary ID
Status Recruiting
Phase N/A
First received August 11, 2015
Last updated August 14, 2015
Start date July 2015
Est. completion date March 2017

Study information
Verified date August 2015
Source Bracane Company
Contact Pamela Nelson, RN, MS, PhD
Phone 888-568-4271
Email pjnelson@bracaneco.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date March 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Observation
Observation and evaluation of care provided to patients that received DNA tests to determine metabolic pathways.

Locations
Country Name City State
United States Sevierville Foot and Ankle Clinic Sevierville Tennessee

Sponsors (2)
Lead Sponsor Collaborator
Bracane Company IFG Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identify individual variations in metabolic pathways of 2C19, 2C9, 2D6, 3A4, 3A5, Factor II, Factor V, MTHFR and VKORC1 Patients with variations in metabolic pathways of 2C19, 2C9, 2D6, 3A4, 3A5, Factor II, Factor V, MTHFR and VKORC1 that may inhibit the normal metabolism of medications that are metabolized through these pathways will be identified and care received observed for changes in healthcare plan. 18 months No
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