RECRUITING

The Texas Interprofessional Pharmacogenomics (IPGx)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Texas Interprofessional Pharmacogenomics (IPGx) PILOT Cohort

Quick Facts

Study Start:2021-12-15
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06219720

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * People taking 5 or more medications, including over the counter drugs, supplements, natural products, cannabis produces, or other recreational drugs
  2. * Ability to give and comprehend the consent process.
  3. * Consent to donate urine samples, genetic data through buccal swabs, undergo a comprehensive history and physical examination.
  4. * All genders.
  5. * Age 45 and over
  1. * 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.
  2. * Admitted to hospice.
  3. * Patient has ever been diagnosed with Hepatitis B or C.
  4. * 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
  5. * Patients taking imidazole antifungal medication.
  6. * Declines to participate or interact with staff/share their medical status.
  7. * A diagnosis of Alzheimer's disease
  8. * Pregnant patients will be excluded
  9. * Unable/unwilling to consent.
  10. * Unable to verbally communicate and comprehend English/Spanish language.

Contacts and Locations

Study Contact

Kenneth S Ramos, MD
CONTACT
7136777740
kramos@tamu.edu

Principal Investigator

Kenneth S Ramos, MD
PRINCIPAL_INVESTIGATOR
Texas A&M IBT

Study Locations (Sites)

The Interprofessional Pharmacogenomics (IPGx) Clinic
Bryan, Texas, 77802
United States

Collaborators and Investigators

Sponsor: Texas A&M University

  • Kenneth S Ramos, MD, PRINCIPAL_INVESTIGATOR, Texas A&M IBT

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-15
Study Completion Date2027-11

Study Record Updates

Study Start Date2021-12-15
Study Completion Date2027-11

Terms related to this study

Additional Relevant MeSH Terms

  • Adverse Drug Reaction