NCT02487888

A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care

Randomized, Blinded, Controlled Trial to EValuate the EcOnomic and ClinicaL Outcomes of Utilizing Genetic Testing to Improve Therapeutic Decision-Making COmpared to Empiric Prescribing as the StaNdard of Care

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100,000 (estimated)
• Sponsor: Proove Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the impact of genetic testing on healthcare decisions and patient outcomes for patients suffering from pain, cardiovascular problems, Arthritis, Type II Diabetes, and/or Mental Health disorders. Results of genetic testing will also be compared with the clinical outcome measures collected to discover novel genetic factors that may influence patient care.

Detailed description

The molecular basis of many pharmacogenetic polymorphisms has now been elucidated, with genetic variations resulting in alteration of expression or function of receptors, enzymes, and transporters relevant to the safety and efficacy of a medical treatment. Genetics has been shown to be a significant factor in the variability of responses of medication choices and doses. With the rapid development of cost-effective high throughput molecular genotyping methods, pharmacogenetics has become increasingly important because of its potential to identify patients with increased risk of adverse drug reactions or decreased likelihood of response at standard dosage of drug. By identifying the genetic risks and the most effective therapy for an individual patient, clinicians may improve the efficacy of treatment and decrease the risk of adverse drug events. The addition of pharmacogenetic testing to routine clinical practice may also be extremely helpful because of the cost reduction associated with the identification of patients that will not respond to expensive drugs or with the identification of patients likely to suffer from severe adverse events. There are also tremendous efforts in the pharmaceutical industry to lower the cost for drug development; pharmacogenetics may fulfill the need to provide the right drug to the right patient and to increase the likelihood of success of large phase II and phase III clinical trials. The purpose of this study is to evaluate how currently available genetic tests are being implemented in various clinics around the United States, and whether this information results in benefits to patient care. Patients presenting to clinics with pain, cardiovascular conditions, Arthritis, Type II Diabetes, and/or Mental Health disorders that are receiving Proove Bioscience's genetic testing will complete validated questionnaires to measure specific outcomes related to their treatment at each clinical visit, including medication efficacy, reduction in adverse drug events, and healthcare utilization. Physicians will document any changes made to treatment regimens, including adjustments to medications or non-pharmacological treatments, and any improvements in the outcome measures. Statistical analysis will be performed to calculate relationships between genotypic and phenotypic data points collected in this study. The results of this study will provide a measurable understanding of the medical and economic value of implementing genetic testing into clinical care. Furthermore, data points collected will be used to examine novel correlations and associations between single nucleotide polymorphisms and longitudinal clinical outcome measures.

Conditions

• Pain
• Chronic Pain
• Mental Disorders
• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Arthritis

Interventions

Type	Name	Description
OTHER	Unblinded to Genetic Testing Results	The physicians of this group of patients will be unblinded to the results of the genetic testing.
OTHER	Blinded to Genetic Testing Results	The physicians of this group of patients will be blinded to the results of the genetic testing. They will be un-blinded to the results of each patient once that patient has completed the study.

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2015-07-02
• Last updated: 2016-03-30

Locations

31 sites across 1 country: United States