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

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ClinicalTrials.gov Identifier: NCT02525887
Recruitment Status : Terminated (Study cancelled)
First Posted : August 18, 2015
Last Update Posted : May 6, 2016
Sponsor:
Collaborator:
IFG Medical
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Chronic Disease Endocrine System Disease Cardiovascular Disease Respiratory Tract Disease CNS Metabolic Disorders 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.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Study Start Date : July 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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


Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02525887


Locations
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United States, Tennessee
Sevierville Foot and Ankle Clinic
Sevierville, Tennessee, United States, 37862
Sponsors and Collaborators
Bracane Company
IFG Medical
Investigators
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Study Director: Kirk Allan IFG Medical

Additional Information:
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Responsible Party: Bracane Company
ClinicalTrials.gov Identifier: NCT02525887     History of Changes
Other Study ID Numbers: IFG201502-PGX
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Brain Diseases, Metabolic
Metabolic Diseases
Chronic Disease
Cardiovascular Diseases
Respiratory Tract Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases