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



Status:Enrolling by invitation
Conditions:Arthritis, Arthritis, Chronic Pain, Chronic Pain, Chronic Pain, Peripheral Vascular Disease, Psychiatric, Psychiatric, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Musculoskeletal, Psychiatry / Psychology, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2014
End Date:December 2016

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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

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.

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.

Inclusion Criteria:

- Provide signed and dated informed consent form

- Willing to comply with all study procedures and be available for the duration of the
study

- Male or Female, at least 18 years of age

- Currently taking or a candidate for medication

- Documented or recent complaint within 90 days with initial date of onset

Exclusion Criteria:

- Severe hepatic or renal disease (where current pharmaceutical dosing is affected
and/or requires adjustment of standard dosing prior to PGx testing)

- Significant diminished mental capacity that is unable to understand the protocol,
surveys and questionnaires; unable to read/write English or Spanish.

- Recent febrile illness that precludes or delays participation by more than 1 month

- Pregnancy or lactation

- Participation in a clinical study that may interfere with participation in this study

- Anything that would place the individual at increased risk or preclude the
individual's full compliance with or completion of the study.
We found this trial at
31
sites
Vandalia, Ohio 45414
1897
mi
from 91732
Vandalia, OH
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Altoona, Pennsylvania 16601
2203
mi
from 91732
Altoona, PA
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Baltimore, Maryland 21224
2301
mi
from 91732
Baltimore, MD
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Beverly Hills, California 90211
22
mi
from 91732
Beverly Hills, CA
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Beverly Hills, California 90212
22
mi
from 91732
Beverly Hills, CA
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Beverly Hills, California 90212
22
mi
from 91732
Beverly Hills, CA
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Boca Raton, Florida 33428
2305
mi
from 91732
Boca Raton, FL
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Chattanooga, Tennessee 37416
1860
mi
from 91732
Chattanooga, TN
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Davie, Florida 33328
2310
mi
from 91732
Davie, FL
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Fort Lauderdale, Florida 33316
2317
mi
from 91732
Fort Lauderdale, FL
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Fort Lauderdale, Florida 33316
2317
mi
from 91732
Fort Lauderdale, FL
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Fort Lauderdale, Florida 33334
2314
mi
from 91732
Fort Lauderdale, FL
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Fort Wayne, Indiana 46825
1852
mi
from 91732
Fort Wayne, IN
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Fresno, California 93710
209
mi
from 91732
Fresno, CA
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Fresno, California 93726
209
mi
from 91732
Fresno, CA
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Greer, South Carolina 29651
2027
mi
from 91732
Greer, SC
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Hixson, Tennessee 37343
1856
mi
from 91732
Hixson, TN
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La Jolla, California 92037
95
mi
from 91732
La Jolla, CA
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Littleton, Massachusetts 01460
2554
mi
from 91732
Littleton, MA
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Los Angeles, California 90017
13
mi
from 91732
Los Angeles, CA
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Louisville, Kentucky 40214
1812
mi
from 91732
Louisville, KY
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Macon, Georgia 31210
1967
mi
from 91732
Macon, GA
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Morristown, Tennessee 37813
1958
mi
from 91732
Morristown, TN
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Murrieta, California 92563
58
mi
from 91732
Murrieta, CA
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Portland, Oregon 97216
828
mi
from 91732
Portland, OR
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Rolling Hills, California 90274
29
mi
from 91732
Rolling Hills, CA
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San Diego, California 92122
96
mi
from 91732
San Diego, CA
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Sandpoint, Idaho 83864
984
mi
from 91732
Sandpoint, ID
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Spokane, Washington 99006
956
mi
from 91732
Spokane, WA
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Torrance, California 90501
24
mi
from 91732
Torrance, CA
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Vista, California 92083
74
mi
from 91732
Vista, CA
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