What this study is
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.
Study details
- Official title
- The Texas Interprofessional Pharmacogenomics (IPGx) PILOT Cohort
- Sponsor
- Texas A&M University
- Conditions
- Adverse Drug Reaction
- Enrolling
- 50 people
- Starts
- 2021-12-15
- Est. completion
- 2027-11
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 45 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- People 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, undergo a comprehensive history and physical examination.
- All genders.
- Age 45 and over
You can't join if
- 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
- Patients taking imidazole antifungal medication.
- Declines to participate or interact with staff/share their medical status.
- A diagnosis of Alzheimer's disease
- Pregnant patients will be excluded
- Unable/unwilling to consent.
- Unable to verbally communicate and comprehend English/Spanish language.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe Interprofessional Pharmacogenomics (IPGx) Clinic
Bryan, Texas, United States
- Gabriel Neal, MD · Contact979-436-0399gneal@tamu.edu
- DeLona Bacote, MS · Contact713-677-7735dabacote@tamu.edu
- Kenneth S Ramos, MD,PhD · Principal investigator
- Gabriel Neal, MD · Sub-investigator
- Sara Rogers, PharmD · Sub-investigator
- George Udeani, PharmD · Sub-investigator
- Asim Abu-Baker, PharmD · Sub-investigator
- Rick Silva, PhD, MBA · Sub-investigator
Recruiting
Study team
Sponsor
Texas A&M University
Study ID IRB2021-0860F
Principal investigator
Kenneth S Ramos, MD
Texas A&M IBT
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.