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

Terminated

• Conditions: Respiratory Tract Disease; CNS Metabolic Disorders; Endocrine System Disease; Cardiovascular Disease; Chronic Disease

• Registration Number: NCT02525887
• Lead Sponsor: Bracane Company

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 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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-18
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-04
• Last Update Posted: 2016-05-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify individual variations in metabolic pathways of 2C19, 2C9, 2D6, 3A4, 3A5, Factor II, Factor V, MTHFR and VKORC1	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.

Trial Locations

Locations (1)

Sevierville Foot and Ankle Clinic; 🇺🇸 Sevierville, Tennessee, United States