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

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.

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Disease; Chronic Disease; Endocrine System Disease; Respiratory Tract Disease; CNS Metabolic Disorders
• Intervention / Treatment: Other: Observation

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Sevierville, Tennessee, United States, 37862
      • Sevierville Foot and Ankle Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Data from a total of approximately 10,000 adult male or female patients age 18 or older who are prescribed at least one medication within any of the metabolic pathways being assessed will be collected for the study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bracane Company
• Collaborators: IFG Medical
• Investigators: Study Director: Kirk Allan, IFG Medical

Publications and helpful links

Helpful Links

• Website for site members and investigators to obtain information about opportunity.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: August 11, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 18, 2015

Study Record Updates

• Last Update Posted (Estimate): May 6, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Cardiovascular Diseases; Chronic Disease; Endocrine System Diseases; Metabolic Diseases; Respiratory Tract Diseases; Brain Diseases, Metabolic
• Other Study ID Numbers: IFG201502-PGX