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

Not Applicable

Recruiting

• Conditions: Cancer; Advanced Solid Tumor; Behavior Disorders; Advanced Cancer; Mental Health Issue

• Registration Number: NCT05166694
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-22
• Study Start: 2022-11-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-05
• Primary Completion: 2027-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1300

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Rate of Drug-Drug Interactions and Drug-Gene Interactions Among Participants	9 months	The change in the composite rate of drug-drug interactions (DDIs) and drug-gene interactions (DGIs) from baseline (at beginning of study) and after each intervention compared between all three arms.

Secondary Outcome Measures

Name	Time	Method
Rate of Reported Adverse Events as Assessed by Clinical Records	9 months	Rate of reported adverse drug events among participants in all three arms as assessed by study notes/clinical record.
Strategy to Implement at Personalize Therapeutic Clinic (PTC) at Specific Sites Based on Available Mediators (PTC Partners)	9 months	An implementation strategy for a site-specific Personalized Therapeutic Clinic (PTC) as assessed by evaluating which mediators and moderators who may be able to adopt PTC recommendations.
Rate of Emergency Department Visits	9 months	Rate of emergency department visits among participants in all three arms as assessed by study notes/clinical record.
Changes in Participant Knowledge and Perceptions of the Personalized Therapeutic Clinic (PTC) as Assessed by Survey Results	9 months	Changes in participant knowledge and perceptions of the PTC will be assessed using surveys administered at baseline and after the first post-PTC visit with their primary treating provider.
Participants At High-Risk for Drug-Drug and Drug-Gene Interactions	9 months	Reported as a percentage of total hospitalized participants
Rate of Hospitalizations	9 months	The rate of hospitalizations among participants in all three arms as assessed by study notes/clinical record.
Changes in provider knowledge and perceptions of the Personalized Therapeutic Clinics (PTC) Assessed by Survey Results	9 months	Changes in provider knowledge and perceptions of the PTC as assessed by survey collected from providers at baseline and at the end of study.

Trial Locations

Locations (1)

University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States