Clinical trial NCT02525887: Identify Genetic Variations That Affect The Ability of Patients To Metabolize Drugs Through Metabolic Pathways
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Disease
Endocrine System Disease
Cardiovascular Disease
Respiratory Tract Disease
CNS Metabolic Disorders
Lead sponsor: Bracane Company
Sponsor class: INDUSTRY
Collaborators: name: IFG Medical
First posted: 2015-08-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Identify individual variations in metabolic pathways of 2C19, 2C9, 2D6, 3A4, 3A5, Factor II, Factor V, MTHFR and VKORC1
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sevierville
country: United States
facility: Sevierville Foot and Ankle Clinic
state: Tennessee
Study officials:
affiliation: IFG Medical
name: Kirk Allan
role: STUDY_DIRECTOR
References: