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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02525887

Enrollment

Registered

2015-08-18

Start date

2015-07-31

Completion date

2016-01-31

Last updated

2016-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERObservation

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

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026