Clinical trial NCT05166694: Evaluating Personalized Therapeutics Clinic (PTC) on Drug-Drug Interactions and Drug-Gene Interactions
Official title: Evaluating the Effectiveness of a Personalized Therapeutics Clinic (PTC) Intervention on Drug-Drug Interactions (DDIs) and Drug-Gene Interactions (DGIs)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Advanced Cancer
Advanced Solid Tumor
Mental Health Issue
Behavior Disorders
Keywords: tumor
advanced cancer
advanced solid tumor
cancer medication
prescriptions
inhibitor drug
inducer drug
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria for Participants

1. Participants who have undergone, or are being actively considered for, liver or kidney transplantation.
2. Participation in another pharmacogenomic study.
3. Participants who have previously received genotyping from another source.
4. 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.

Primary outcomes:
measure: Change in Rate of Drug-Drug Interactions and Drug-Gene Interactions Among Participants
timeFrame: 9 months
Secondary outcomes:
measure: Participants At High-Risk for Drug-Drug and Drug-Gene Interactions
timeFrame: 9 months
measure: Strategy to Implement at Personalize Therapeutic Clinic (PTC) at Specific Sites Based on Available Mediators (PTC Partners)
timeFrame: 9 months
measure: Rate of Hospitalizations
timeFrame: 9 months
measure: Rate of Emergency Department Visits
timeFrame: 9 months
measure: Rate of Reported Adverse Events as Assessed by Clinical Records
timeFrame: 9 months
measure: Changes in Participant Knowledge and Perceptions of the Personalized Therapeutic Clinic (PTC) as Assessed by Survey Results
timeFrame: 9 months
measure: Changes in provider knowledge and perceptions of the Personalized Therapeutic Clinics (PTC) Assessed by Survey Results
timeFrame: 9 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
Study officials:
affiliation: University of Chicago
name: Mark Ratain, MD
role: PRINCIPAL_INVESTIGATOR
References: