Clinical trial NCT06726590: Interprofessional Pharmacogenomics (IPGx) Registry and Repository
Official title: The Texas Interprofessional Pharmacogenomics Registry and Repository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Cholesterol
Cancer
Blood Pressure Disorders
Heart Disease
Respiratory Ilness
COPD
Adverse Drug Reaction (ADR)
Poly Pharmacy
Keywords: REGISTRY
REPOSITORY
POLYPHARMACY
ADVERSE DRUG REACTION
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Texas A\&M Health clinical programs.

Brief summary: This program collects genetic and health information to help doctors choose the right medications for patients.

Detailed description: This study wants to understand how genes can affect how the body responds to medicines. This information will help us determine whether changing your medicine can make you healthier and improve your life. We will study your medical history for the last year and the next five years after you join the study.

study goals include:

* Enrolling patients who take multiple medications or have harmful side effects from their medications.
* Keeping all medical information and genetic samples from patients in one place.
* Helping doctors make better decisions about which medicines to prescribe.
* Influencing insurance companies and the government to help pay for this kind of medical care for people who need to change their medicine to stay healthy.

Eligibility criteria: Inclusion Criteria:

* The study will invite patients who are eligible for PGX workup/PGX care to participate, provided they meet the following criteria: Use of five or more medications, including over the counter drugs, supplements, natural products, cannabis products, or other recreational drugs, or
* Individuals taking blood pressure or depression medications, even if less than five medications.
* Ability to understand and give consent.
* Able to consent to donate blood and/or urine samples and buccal swabs.
* Able to answer detailed questionnaires, including quarterly questionnaires about ADRs, cognitive testing such as serial mini-mental status exams, and or quality of life questions.
* Able to understand that their health record and changes in health status will be followed for a five-year period and shared in deidentified form with the research community.
* All genders.
* Any age over 18 years.

Exclusion Criteria:

* Individuals admitted to hospice.
* Declines to participate or interact with staff/share their medical status.
* A diagnosis of Alzheimer's disease or related dementias in a medical record as this indicates a progressive, debilitating condition that impairs memory, thought processes, and functioning.,
* Individuals who are unable or unwilling to provide consent.
* Unable to verbally communicate and comprehend English language

Primary outcomes:
measure: Frequency and nature of ADRs on the Naranjo Scale
timeFrame: 5 years
Secondary outcomes:
measure: Serum/plasma drug concentrations
timeFrame: 5 years
Other outcomes:
measure: Pharmacogenomic genotype with corresponding ADR phenotype
timeFrame: 5 years
measure: Drug-drug interactions, drug gene interactions, drug-drug-gene interactions
timeFrame: 5 years
Locations:
city: Bryan
country: United States
facility: Texas A&M Family Care
state: Texas
Study officials:
References: