Back to resultsEvaluating Personalized Therapeutics Clinic (PTC) on Drug-Drug Interactions and Drug-Gene Interactions
Primary Purpose
Cancer, Advanced Cancer, Advanced Solid Tumor
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Drug-Drug Interaction Profile
Drug-Gene Interaction Profile
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring tumor, advanced cancer, advanced solid tumor, cancer medication, prescriptions, inhibitor drug, inducer drug
Eligibility Criteria
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.
Sites / Locations
- University of Chicago MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
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)
Arm 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.
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 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Participants At High-Risk for Drug-Drug and Drug-Gene Interactions
Reported as a percentage of total hospitalized participants
Strategy to Implement at Personalize Therapeutic Clinic (PTC) at Specific Sites Based on Available Mediators (PTC Partners)
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.
Rate of Hospitalizations
The rate of hospitalizations among participants in all three arms as assessed by study notes/clinical record.
Rate of Emergency Department Visits
Rate of emergency department visits among participants in all three arms as assessed by study notes/clinical record.
Rate of Reported Adverse Events as Assessed by Clinical Records
Rate of reported adverse drug events among participants in all three arms as assessed by study notes/clinical record.
Changes in Participant Knowledge and Perceptions of the Personalized Therapeutic Clinic (PTC) as Assessed by Survey Results
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.
Changes in provider knowledge and perceptions of the Personalized Therapeutic Clinics (PTC) Assessed by Survey Results
Changes in provider knowledge and perceptions of the PTC as assessed by survey collected from providers at baseline and at the end of study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05166694
Brief Title
Evaluating Personalized Therapeutics Clinic (PTC) on Drug-Drug Interactions and Drug-Gene Interactions
Official Title
Evaluating the Effectiveness of a Personalized Therapeutics Clinic (PTC) Intervention on Drug-Drug Interactions (DDIs) and Drug-Gene Interactions (DGIs)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Advanced Cancer, Advanced Solid Tumor, Mental Health Issue, Behavior Disorders
Keywords
tumor, advanced cancer, advanced solid tumor, cancer medication, prescriptions, inhibitor drug, inducer drug
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Prescribing Based on Information From Both Drug-Drug and Drug-Gene Profiles
Arm Type
Experimental
Arm 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.
Arm Title
Group 2: Prescribing Based ONLY on Information From Drug-Drug Interaction Profiles
Arm Type
Experimental
Arm 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.
Arm Title
Group 3: Prescribing Not Based on ANY Profile Information (Drug-Drug or Drug-Gene Interactions)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Drug-Drug Interaction Profile
Intervention Description
A profile based on genetic testing that shows information about how the participant's medications they are taking interact with each other.
Intervention Type
Other
Intervention Name(s)
Drug-Gene Interaction Profile
Intervention Description
A profile based on genetic testing that shows information about how the participant's genes interact with/respond to certain medications they are taking.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
The standard treatment and prescribing for the participant's specific type of cancer.
Primary Outcome Measure Information:
Title
Change in Rate of Drug-Drug Interactions and Drug-Gene Interactions Among Participants
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Participants At High-Risk for Drug-Drug and Drug-Gene Interactions
Description
Reported as a percentage of total hospitalized participants
Time Frame
9 months
Title
Strategy to Implement at Personalize Therapeutic Clinic (PTC) at Specific Sites Based on Available Mediators (PTC Partners)
Description
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.
Time Frame
9 months
Title
Rate of Hospitalizations
Description
The rate of hospitalizations among participants in all three arms as assessed by study notes/clinical record.
Time Frame
9 months
Title
Rate of Emergency Department Visits
Description
Rate of emergency department visits among participants in all three arms as assessed by study notes/clinical record.
Time Frame
9 months
Title
Rate of Reported Adverse Events as Assessed by Clinical Records
Description
Rate of reported adverse drug events among participants in all three arms as assessed by study notes/clinical record.
Time Frame
9 months
Title
Changes in Participant Knowledge and Perceptions of the Personalized Therapeutic Clinic (PTC) as Assessed by Survey Results
Description
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.
Time Frame
9 months
Title
Changes in provider knowledge and perceptions of the Personalized Therapeutic Clinics (PTC) Assessed by Survey Results
Description
Changes in provider knowledge and perceptions of the PTC as assessed by survey collected from providers at baseline and at the end of study.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andre Hall
Phone
(773)834-0936
Email
andrehall@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Ratain, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Hall
Phone
773-834-0936
Email
andrehall@bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Mark Ratain
12. IPD Sharing Statement
Learn more about this trial
Evaluating Personalized Therapeutics Clinic (PTC) on Drug-Drug Interactions and Drug-Gene Interactions
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