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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05166694
Other study ID # IRB21-1527
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 30, 2022
Est. completion date November 1, 2025

Study information

Verified date April 2023
Source University of Chicago
Contact Andre Hall
Phone (773)834-0936
Email andrehall@bsd.uchicago.edu
Is FDA regulated No
Health authority
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.

Study Design


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
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