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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

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

Brief 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.

Detailed Summary: 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.
Sponsor: Bracane Company

Current Primary Outcome: Identify individual variations in metabolic pathways of 2C19, 2C9, 2D6, 3A4, 3A5, Factor II, Factor V, MTHFR and VKORC1 [ Time Frame: 18 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bracane Company

Dates:
Date Received: August 11, 2015
Date Started: July 2015
Date Completion:
Last Updated: May 4, 2016
Last Verified: May 2016