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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05166694
• Other study ID #: IRB21-1527
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: Andre Hall
• Phone: (773)834-0936
• Email: andrehall[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Advanced Solid Tumor
• Behavior Disorders
• Cancer
• Mental Disorders
• Mental Health Issue

Intervention

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.
• 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.
• Standard of Care
The standard treatment and prescribing for the participant's specific type of cancer.

Locations

Country	Name	City	State
United States	University of Chicago Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Rate of Drug-Drug Interactions and Drug-Gene Interactions Among Participants	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.	9 months
Secondary	Participants At High-Risk for Drug-Drug and Drug-Gene Interactions	Reported as a percentage of total hospitalized participants	9 months
Secondary	Strategy to Implement at Personalize Therapeutic Clinic (PTC) at Specific Sites Based on Available Mediators (PTC Partners)	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.	9 months
Secondary	Rate of Hospitalizations	The rate of hospitalizations among participants in all three arms as assessed by study notes/clinical record.	9 months
Secondary	Rate of Emergency Department Visits	Rate of emergency department visits among participants in all three arms as assessed by study notes/clinical record.	9 months
Secondary	Rate of Reported Adverse Events as Assessed by Clinical Records	Rate of reported adverse drug events among participants in all three arms as assessed by study notes/clinical record.	9 months
Secondary	Changes in Participant Knowledge and Perceptions of the Personalized Therapeutic Clinic (PTC) as Assessed by Survey Results	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.	9 months
Secondary	Changes in provider knowledge and perceptions of the Personalized Therapeutic Clinics (PTC) Assessed by Survey Results	Changes in provider knowledge and perceptions of the PTC as assessed by survey collected from providers at baseline and at the end of study.	9 months