Menu
Recruiting NCT05166694

Evaluating Personalized Therapeutics Clinic (PTC) on Drug-Drug Interactions and Drug-Gene Interactions

No phase Interventional Cancer Advanced Cancer Advanced Solid Tumor Mental Health Issue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Drug-Drug Interaction Profile, Drug-Gene Interaction Profile, Standard of Care.
Who it may be relevant to
Registry conditions: Cancer, Advanced Cancer, Advanced Solid Tumor, Mental Health Issue. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluating the Effectiveness of a Personalized Therapeutics Clinic (PTC) Intervention on Drug-Drug Interactions (DDIs) and Drug-Gene Interactions (DGIs)

Overview

The purpose of this study is to determine whether a consultation with a Personalized Therapeutics Clinic, or PTC, will help participants lower the risk for side effects (drug-drug interactions and drug-gene interactions) when taking many medications and help providers improve prescribing decisions for participants. A PTC is a clinical that will test your genes to gather information about your health that may help guide prescribing advice and offer you new information about your prescriptions. Doctors leading this study will look for variations (differences) in your genes that may suggest that you are at greater risk of having side effects or a greater chance of benefiting from certain medications. Individuals in this study will participate for roughly 9 months.

Interventions

  • Other Drug-Drug Interaction Profile
    A profile based on genetic testing that shows information about how the participant's medications they are taking interact with each other.
  • Other Drug-Gene Interaction Profile
    A profile based on genetic testing that shows information about how the participant's genes interact with/respond to certain medications they are taking.
  • Other Standard of Care
    The standard treatment and prescribing for the participant's specific type of cancer.

Primary outcome measures

  • Change in Rate of Drug-Drug Interactions and Drug-Gene Interactions Among Participants [Time frame: 9 months]
Secondary outcome measures (7)
  • Participants At High-Risk for Drug-Drug and Drug-Gene Interactions [Time frame: 9 months]
  • Strategy to Implement at Personalize Therapeutic Clinic (PTC) at Specific Sites Based on Available Mediators (PTC Partners) [Time frame: 9 months]
  • Rate of Hospitalizations [Time frame: 9 months]
  • Rate of Emergency Department Visits [Time frame: 9 months]
  • Rate of Reported Adverse Events as Assessed by Clinical Records [Time frame: 9 months]
  • Changes in Participant Knowledge and Perceptions of the Personalized Therapeutic Clinic (PTC) as Assessed by Survey Results [Time frame: 9 months]
  • Changes in provider knowledge and perceptions of the Personalized Therapeutic Clinics (PTC) Assessed by Survey Results [Time frame: 9 months]

Eligibility criteria

Inclusion criteria

  • Adult participants cared for by a participating provider at University of Chicago Medical Center.
  • Participants must be at least 18 years of age.
  • Participants prescribed 5 or medication medications and taking a perpetrator drug or a drug with actionable pharmacogenomic information.

Exclusion Criteria for Participants

  • Participants who have undergone, or are being actively considered for, liver or kidney transplantation.
  • Participation in another pharmacogenomic study.
  • Participants who have previously received genotyping from another source.
  • Inability to understand and give informed consent to participate.

Inclusion of Women, Minorities, and Other Underrepresented Populations Individuals of all races and ethnic groups and genders are eligible for this trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Chicago Medicine — Chicago

Identifiers

NCT: NCT05166694 · IRB21-1527

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗