IPGx PILOT Whole Genome Sequencing Extension Cohort
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorTexas A&M University
About this trial
The investigator's primary aim is to evaluate polypharmacy-associated adverse drug reactions (ADR) in a pilot study of at-risk patients using state-of-the-art pharmacogenomic technology and to use this information to make recommendations for optimization of pharmacotherapy regimens. The data from the pilot cohort will be used to optimize and integrate a customized electronic decision support (clinical semantic network; CSN) dashboard to identify drug regimens that should be modified, replaced, or discontinued. A secondary objective of the pilot study is to evaluate the capacity/saturation of CYP P450 enzymatic pathways in polypharmacy patients. A third objective is to determine the feasibility of the planned informatics workflows between the CLIA lab, the EMR, and the Family Medicine Practice including Whole Genome Sequencing (WGS).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals taking 5 or more medications, including over the counter drugs, supplements, natural products, cannabis produces, or other recreational drugs.
Ability to give and comprehend the consent process.
Consent to donate urine samples, genetic data through buccal swabs and blood samples, and undergo a comprehensive history and physical examination.
All genders
Disqualifiers
Subject has been diagnosed or is being treated for any cancer other than basal cell cancer in the last 5 years. Patients with metastatic melanoma in the last 5 years will be excluded.
Admitted to hospice.
Patient has ever been diagnosed with Hepatitis B or C.
Patient has ever been diagnosed with active liver disease, hepatomegaly, grossly abnormal liver function. Meld score >10, ALT, or AST >100U/L or an AST/ALT ratio >2
Trial population
The study plans to recruit at most 50 volunteers from the Texas A\&M affiliated community health family medicine program.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Pharmacogenomic genotype with corresponding ADR phenotype
Patients will be referred to the Texas A\&M Interprofessional Pharmacogenomics Clinic (IPGx) by their primary care physicians to evaluate genotyping and ADR. Clinical staff will obtain a buccal swab to collect DNA for a pharmacogenomic evaluation pursuant to the sample collection kits from the CLIA lab, which will occur at the start of the study period. Blood chemistry will be taken from the EMR.
Time frame
180 daysSecondary outcomes
1
Emergency department visits
A secondary objective of the pilot study is to evaluate \& monitor the frequency of Emergency department visits.
Time frame
180 daysOther outcomes
1
Drug-drug interactions, drug gene interactions, drug-drug-gene interactions
An assessment at the IPGx will start with the pharmacist or physician doing a pharmacologic consultation to evaluate medications or other drugs currently being used by the patient and to identify any potential issues related to toxicity, drug interactions, or side effects that might be relevant to the clinical presentation.
Time frame
180 days2
Frequency and nature of ADRs on the Naranjo Scale
Patients will be referred to the Texas A\&M Interprofessional Pharmacogenomics Clinic (IPGx) by their primary care physicians. A physician or ambulatory pharmacist in the IPGx clinic or Family Care Clinic will obtain a complete medical history, physical examination, and validate the patient's current concomitant medication list at the IPGx during the office visit. Patient medical information would be input into the ActX platform, which functions as a computable EHR medical record analysis, evaluation of polypharmacy status, and monitoring of ADRs using the Naranjo Scale (19) will be conducted for the duration of the study.
Time frame
180 daysSponsors and contacts
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Source ClinicalTrials.gov