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Genetic Testing

Personalized Medication Management for Multiple Medications Safety

N/A
Recruiting
Led By Tien Truong, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants prescribed 5 or medication medications and taking a perpetrator drug or a drug with actionable pharmacogenomic information
Participants must be at least 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

Study Summary

This trial seeks to see if a personalized clinic can help lower risk of side effects & improve prescribing decisions when taking multiple medications. Doctors will look for variations in genes to suggest risk of side effects or chance of benefiting from meds. Trial length: 9 months.

Who is the study for?
This trial is for adults over 18 at the University of Chicago Medical Center who take 5 or more medications, including those with specific drug interactions or genetic factors affecting medication response. It's not for those with liver/kidney transplants, in other gene studies, or unable to consent.Check my eligibility
What is being tested?
The study tests if a Personalized Therapeutics Clinic (PTC) can reduce side effects by analyzing participants' genes and current medications. The PTC aims to improve prescribing decisions based on drug-drug and drug-gene interactions over a period of roughly 9 months.See study design
What are the potential side effects?
Since this trial involves personalized advice rather than new drugs, direct side effects from interventions are minimal. However, changes in medication regimens could lead to typical prescription-related side effects depending on individual adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am taking 5 or more medications, including one that requires genetic testing.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Rate of Drug-Drug Interactions and Drug-Gene Interactions Among Participants
Secondary outcome measures
Changes in Participant Knowledge and Perceptions of the Personalized Therapeutic Clinic (PTC) as Assessed by Survey Results
Changes in provider knowledge and perceptions of the Personalized Therapeutic Clinics (PTC) Assessed by Survey Results
Participants At High-Risk for Drug-Drug and Drug-Gene Interactions
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3: Prescribing Not Based on ANY Profile Information (Drug-Drug or Drug-Gene Interactions)Experimental Treatment1 Intervention
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.
Group II: Group 2: Prescribing Based ONLY on Information From Drug-Drug Interaction ProfilesExperimental Treatment1 Intervention
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.
Group III: Group 1: Prescribing Based on Information From Both Drug-Drug and Drug-Gene ProfilesExperimental Treatment2 Interventions
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.

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
997 Previous Clinical Trials
816,398 Total Patients Enrolled
Tien Truong, MDPrincipal InvestigatorUniversity of Chicago - Comprehensive Cancer Center
Mark Ratain, MDPrincipal InvestigatorUniversity of Chicago
3 Previous Clinical Trials
350 Total Patients Enrolled

Media Library

Personalized Therapeutics Clinic (PTC) (Genetic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT05166694 — N/A
Cancer Research Study Groups: 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, Group 3: Prescribing Not Based on ANY Profile Information (Drug-Drug or Drug-Gene Interactions)
Cancer Clinical Trial 2023: Personalized Therapeutics Clinic (PTC) Highlights & Side Effects. Trial Name: NCT05166694 — N/A
Personalized Therapeutics Clinic (PTC) (Genetic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05166694 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been enrolled in this research initiative?

"Affirmative. According to clinicaltrials.gov, this medical experiment has opened for recruitment and is actively seeking participants since November 30th 2022. The trial needs 1300 patients from 1 site to be enrolled in it before the most recent update of December 6th 2022."

Answered by AI

Are there any vacancies available to participants in this clinical trial?

"Affirmative. Information posted to clinicaltrials.gov indicates that this medical trial, first shared on November 30th 2022 and most recently edited on December 6th 2022, is actively recruiting. The research team requires 1300 participants from a single site for the study."

Answered by AI
~396 spots leftby Nov 2024