IPGx PILOT Whole Genome Sequencing Extension Cohort

NCT06766071 | Recruiting DMC

• 1 other identifier: STUDY2024-0724
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Adverse Drug Reaction (ADR); Polypharmacy Patients

Keywords

whole genome sequencing

Outcome Measures

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.

  180 days

Secondary Outcomes (1)

• Emergency department visits

  180 days

Other Outcomes (2)

• Drug-drug interactions, drug gene interactions, drug-drug-gene interactions

  180 days

• Frequency and nature of ADRs on the Naranjo Scale

  180 days

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study plans to recruit at most 50 volunteers from the Texas A\&M affiliated community health family medicine program.

You may qualify if:

• 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
• Age 18-100

You may not qualify 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 or related dementias in a medical record indicates a progressive, debilitating condition that impairs memory, thought processes, and functioning.
• Pregnant patients will be excluded.
• Individuals who are unable or unwilling to provide consent will be excluded.
• Unable to verbally communicate and comprehend English language.

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M Family Care

Bryan, Texas, 77802, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, and cheek swab sample.

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Central Study Contacts

Kenneth S Ramos,, MD

CONTACT

7136777740; kramos@tamu.edu

Rick Silva, PhD

CONTACT

(713) 677-7422; ricksilva@tamu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 180 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 9, 2025
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 9, 2025

Record last verified: 2024-09

Locations

US (1)