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TerminatedNCT02525887Updated May 6, 2016

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

An observational study in Chronic Disease, Endocrine System Disease and Cardiovascular Disease, sponsored by Bracane Company. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-06.

Sponsored by Bracane Company · Observational

Why this study was terminated
Study cancelled
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Disease
  • Endocrine System Disease
  • Cardiovascular Disease
  • Respiratory Tract Disease
  • CNS Metabolic Disorders
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In context

Chronic Disease

1,004 studies on the registry are indexed under Chronic Disease; 174 are open to participants now.

This study's enrollment of 80 is below the median of 402 across 255 observational studies indexed under Chronic Disease.

Browse Chronic Disease studies →

Lead sponsor

Bracane Company is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
80 participants (actual)
Patient registry
No

Interventions

  • OtherObservation

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

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What researchers measure

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.

    Time frame: 18 months

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Study locations

1 site
  • Sevierville Foot and Ankle Clinic
    Sevierville, Tennessee 37862, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02525887
Lead sponsor
Bracane Company
Collaborators
IFG Medical
Responsible party
Sponsor
First posted
Aug 18, 2015
Start date
Jul 2015
Primary completion
Jan 2016
Completion
Jan 2016
Last update
May 6, 2016

Study contacts

Kirk Allan
study director · IFG Medical

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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