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

The University of Chicago

Status: Enrolling

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

Treatments: Other: Drug-Drug Interaction Profile; Other: Drug-Gene Interaction Profile; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05166694

IRB21-1527

Details and patient eligibility

About

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.

Enrollment: 1,300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,300 participants in 3 patient groups

Group 1: Prescribing Based on Information From Both Drug-Drug and Drug-Gene Profiles

Experimental group

Description:

Group one consists of subjects who will participate in the Personalized Therapeutics Clinic where in which study doctors will make recommendations based on information found in both the subject's drug-drug interaction and drug-gene profiles. These recommendations will be given to participating providers. These recommendations will be communicated to healthcare providers who are directing the subject's care. These providers may work in hospitals, primary care, oncology, geriatrics, and mental and behavioral health. Each provider will have separately agreed to participate in this study. Subjects in this group will also learn about their drug-drug interaction and drug-gene profiles during educational visits with clinic staff. Participants will randomly (like by a flip of the coin) assigned to a group.

Treatment:

Other: Drug-Gene Interaction Profile

Other: Drug-Drug Interaction Profile

Group 2: Prescribing Based ONLY on Information From Drug-Drug Interaction Profiles

Experimental group

Description:

Group two consists of subjects who will participate in the Personalized Therapeutics Clinic where study doctors will make recommendations based on information only found in the subject's drug-drug interaction profile. Subjects in this group will also learn about their drug-drug interaction and drug-gene profiles during educational visits with clinic staff. Participants will randomly (like by a flip of the coin) assigned to a group.

Treatment:

Other: Drug-Drug Interaction Profile

Group 3: Prescribing Not Based on ANY Profile Information (Drug-Drug or Drug-Gene Interactions)

Experimental group

Description:

Group three consists of subjects who will not participate in the Personalized Therapeutics Clinic or receive recommendations. These subjects will not have any recommendations from regarding their drug-drug interaction or drug-gene profiles. Both drug-drug interaction and drug-gene profiles will be kept hidden from all of their treating providers-regardless of whether the providers directing their care have agreed to participate in this research. Subjects in this group will not learn about their drug-drug interaction or drug-gene profiles during educational visits with clinic staff. Participants will randomly (like by a flip of the coin) assigned to a group.

Treatment:

Other: Standard of Care