Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study cancelled
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| IFG Medical | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | Observation and evaluation of care provided to patients that received DNA tests to determine metabolic pathways. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kirk Allan | IFG Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sevierville Foot and Ankle Clinic | Sevierville | Tennessee | 37862 | United States |
Not provided
| Label | URL |
|---|---|
| Website for site members and investigators to obtain information about opportunity. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D004700 | Endocrine System Diseases |
| D002318 | Cardiovascular Diseases |
| D012140 | Respiratory Tract Diseases |
| D001928 | Brain Diseases, Metabolic |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided