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NCT Number: NCT05166694

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

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Andre Hall

CONTACT

[email protected]

773-834-0936

Mark Ratain

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

for Participants

  • 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.

Inclusion of Women, Minorities, and Other Underrepresented Populations Individuals of all races and ethnic groups and genders are eligible for this trial.

Treatment and study plan

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.

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.

Standard of care

Other

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

Primary outcomes

  1. Change in Rate of Drug-Drug Interactions and Drug-Gene Interactions Among Participants

    Time frame: 9 months

    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.

Secondary outcomes

  1. Participants At High-Risk for Drug-Drug and Drug-Gene Interactions

    Time frame: 9 months

    Reported as a percentage of total hospitalized participants

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

    Time frame: 9 months

    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.

  3. Rate of Hospitalizations

    Time frame: 9 months

    The rate of hospitalizations among participants in all three arms as assessed by study notes/clinical record.

  4. Rate of Emergency Department Visits

    Time frame: 9 months

    Rate of emergency department visits among participants in all three arms as assessed by study notes/clinical record.

  5. Rate of Reported Adverse Events as Assessed by Clinical Records

    Time frame: 9 months

    Rate of reported adverse drug events among participants in all three arms as assessed by study notes/clinical record.

  6. Changes in Participant Knowledge and Perceptions of the Personalized Therapeutic Clinic (PTC) as Assessed by Survey Results

    Time frame: 9 months

    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.

  7. Changes in provider knowledge and perceptions of the Personalized Therapeutic Clinics (PTC) Assessed by Survey Results

    Time frame: 9 months

    Changes in provider knowledge and perceptions of the PTC as assessed by survey collected from providers at baseline and at the end of study.

Study contacts

Contact information is provided by the study sponsor or research team.

Andre Hall

CONTACT

[email protected]

(773)834-0936

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2021
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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