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

NCT02525887 | Terminated

• 1 other identifier: IFG201502-PGX
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Observation OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult male or female patients age 18 or older
• Prescribed at least one medication with in any of the metabolic pathways being assessed will be enrolled in the study.
• Completed DNA testing for the pathways under review for this observation.

You may not qualify if:

• Anticipated life expectancy less than 1 month.
• 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.

Sponsors & Collaborators

• Bracane Company: lead
• IFG Medical: collaborator

Study Sites (1)

Sevierville Foot and Ankle Clinic

Sevierville, Tennessee, 37862, United States

Location

Related Links

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

MeSH Terms

Conditions

Chronic Disease; Endocrine System Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Brain Diseases, Metabolic

Interventions

Observation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Kirk Allan

  IFG Medical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 18, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 6, 2016

Record last verified: 2016-05

Locations

US (1)