NCT06766071 IPGx PILOT Whole Genome Sequencing Extension Cohort
| NCT ID | NCT06766071 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Texas A&M University |
| Condition | Adverse Drug Reaction (ADR) |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-01 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-01 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06766071 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Adverse Drug Reaction (ADR). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06766071 currently recruiting?
Yes, NCT06766071 is actively recruiting participants. Contact the research team at kramos@tamu.edu for enrollment information.
Where is the NCT06766071 trial being conducted?
This trial is being conducted at Bryan, United States.
Who is sponsoring the NCT06766071 clinical trial?
NCT06766071 is sponsored by Texas A&M University. The trial plans to enroll 50 participants.