Pharmacogenetic Testing for Medication Management.
Status: | Suspended |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/13/2017 |
Start Date: | January 2016 |
End Date: | May 2018 |
Medication Interactions to Detect Adverse Situations
The Study is a single-arm prospective trial of patients receiving at least one medication
with a known association between genetics and drug metabolism. All patients will undergo
genetic testing as determined by their treating physician. The specific genes tested will, in
general, be based upon the drugs the patients are taking or those that the patient's treating
physician is considering as potential substitutes for current medications.
with a known association between genetics and drug metabolism. All patients will undergo
genetic testing as determined by their treating physician. The specific genes tested will, in
general, be based upon the drugs the patients are taking or those that the patient's treating
physician is considering as potential substitutes for current medications.
In this data collection only trial design, the PGx test is not a protocol-specified
procedure. Rather, patients are eligible if they have undergone PGx testing within the last
90 days. Thus, PGx testing will not be performed solely for inclusion in this clinical
research initiative.
procedure. Rather, patients are eligible if they have undergone PGx testing within the last
90 days. Thus, PGx testing will not be performed solely for inclusion in this clinical
research initiative.
Inclusion Criteria:
1. Patient underwent PGx testing for alleles appropriate to the target drugs within the
prior 90 days ("index PGx test");
2. Male or female patients 18 years or older who have given their written Informed
Consent to participate in a Clinical Study based on voluntary agreement a through
explanation of the patient's participation is provided to them. Patients must have
adequate reading and writing abilities such that they can comprehend and answer the
questions on the patient- completed assessments and Informed Consent Form;
3. Patient was receiving at least one medication known to be associated with allelic
variation at the time of the index PGx test), including over-the-counter medications;
5. Patient has a history of at least one TDAE over the 12-month period preceding receipt of
PGx test results, or has experienced inadequate efficacy from a target drug and receiving
medical coverage through a private insurance.
Exclusion Criteria:
1. Patient is currently hospitalized;
2. Patient's medical and medication history is unavailable over the 90-day period
preceding the receipt of PGx testing;
3. Patient is unable to provide an accurate history due to mental incapacity;
4. Patient is known to have undergone prior PGx testing for genes specific to the target
drug(s), exclusive of the PGx test relating to this Study.
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