Recruiting

Personalized Therapeutics

Sponsor:

University of Chicago

Code:

NCT05166694

Conditions

Cancer

Advanced Cancer

Advanced Solid Tumor

Mental Health Issue

Behavior Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Drug-Drug Interaction Profile

Drug-Gene Interaction Profile

Standard of Care

Study Details

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

Cancer

Advanced Cancer

Advanced Solid Tumor

Mental Health Issue

Behavior Disorders

Study ID

NCT05166694

Start date

Nov 30, 2022

Status verified date

Mar, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

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

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.

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

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.

Interventions

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.

Primary outcome measure

  • Change in Rate of Drug-Drug Interactions and Drug-Gene Interactions Among Participants [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Andre Hall

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

Locations

University of Chicago Medicine

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Andre Hall

773-834-0936andrehall@bsd.uchicago.edu

Principal Investigator:

Mark Ratain

More Information

Sponsor

University of Chicago

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-03-04.