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

NCT05166694 | Recruiting

• 1 other identifier: IRB21-1527
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

tumor; advanced cancer; advanced solid tumor; cancer medication; prescriptions; inhibitor drug; inducer drug

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Participants At High-Risk for Drug-Drug and Drug-Gene Interactions

  9 months

• Strategy to Implement at Personalize Therapeutic Clinic (PTC) at Specific Sites Based on Available Mediators (PTC Partners)

  9 months

• Rate of Hospitalizations

  9 months

• Rate of Emergency Department Visits

  9 months

• Rate of Reported Adverse Events as Assessed by Clinical Records

  9 months

Study Arms (3)

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

EXPERIMENTAL

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.

Other: Drug-Drug Interaction Profile; Other: Drug-Gene Interaction Profile

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

EXPERIMENTAL

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.

Other: Drug-Drug Interaction Profile

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

EXPERIMENTAL

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.

Other: Standard of Care

Interventions

Drug-Drug Interaction Profile OTHER

A profile based on genetic testing that shows information about how the participant's medications they are taking interact with each other.

Group 1: Prescribing Based on Information From Both Drug-Drug and Drug-Gene Profiles; Group 2: Prescribing Based ONLY on Information From Drug-Drug Interaction Profiles

Drug-Gene Interaction Profile OTHER

A profile based on genetic testing that shows information about how the participant's genes interact with/respond to certain medications they are taking.

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

Standard of Care OTHER

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Participants who have undergone, or are being actively considered for, liver or kidney transplantation.
• Participation in another pharmacogenomic study.
• Participants who have previously received genotyping from another source.
• Inability to understand and give informed consent to participate.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Mental Disorders

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mark Ratain, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andre Hall

CONTACT

(773)834-0936; andrehall@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 22, 2021
• Study Start: November 30, 2022
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)