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

NCT ID: NCT02525887

Last Updated: 2016-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Chronic Disease Endocrine System Disease Cardiovascular Disease Respiratory Tract Disease CNS Metabolic Disorders

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Observation

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IFG Medical

INDUSTRY

Sponsor Role collaborator

Bracane Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kirk Allan

Role: STUDY_DIRECTOR

IFG Medical

Locations

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Sevierville Foot and Ankle Clinic

Sevierville, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://bracaneco.com

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

Other Identifiers

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IFG201502-PGX

Identifier Type: -

Identifier Source: org_study_id

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