Actively Recruiting

Age: 18Years - 100Years
All Genders
NCT06766071

IPGx PILOT Whole Genome Sequencing Extension Cohort

Led by Texas A&M University · Updated on 2025-01-09

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

IPGx PILOT Whole Genome Sequencing Extension Cohort

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals taking 5 or more medications, including over-the-counter drugs, supplements, natural products, cannabis products, or recreational drugs
  • Ability to understand and provide consent
  • Consent to donate urine, genetic (buccal swab), and blood samples, and undergo a full history and physical exam
  • All genders eligible
  • Age between 18 and 100 years
Not Eligible

You will not qualify if you...

  • Diagnosed or treated for any cancer other than basal cell cancer in the last 5 years; metastatic melanoma in last 5 years excluded
  • Currently admitted to hospice care
  • History of Hepatitis B or C infection
  • Active liver disease or abnormal liver function tests (Meld score >10, ALT or AST >100 U/L, AST/ALT ratio >2)
  • Taking imidazole antifungal medication
  • Declines to participate or share medical information with staff
  • Diagnosis of Alzheimer's disease or related dementias
  • Pregnant individuals
  • Unable or unwilling to provide consent
  • Unable to verbally communicate or understand English language

AI-Screening

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Trial Site Locations

Total: 1 location

1

Texas A&M Family Care

Bryan, Texas, United States, 77802

Actively Recruiting

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Research Team

K

Kenneth S Ramos,, MD

CONTACT

R

Rick Silva, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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