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Pharmacogenetic Testing for Optimizing Drug Therapy (ToPP-UP Trial)
N/A
Recruiting
Led By Julio Duarte, PharmD, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-14 months
Awards & highlights
ToPP-UP Trial Summary
This trial will test if a preemptive clinical pharmacogenetic test can improve patient outcomes by better personalized drug therapy. Data from this trial will also help understand when and how to implement this innovative healthcare technology into clinical care.
Who is the study for?
This trial is for adults over 18 who take at least three prescription drugs and have had a medication change in the last 8 months due to various conditions like depression, heart issues, or chronic pain. It's not for those with past pharmacogenetic testing, organ transplants, kidney dialysis, or less than a year to live.Check my eligibility
What is being tested?
The study tests preemptive pharmacogenetic genotyping—a way to personalize drug therapy based on genetics—to see if it improves patient outcomes. It focuses on underserved groups including racial minorities to ensure broad benefits.See study design
What are the potential side effects?
Since this trial involves genetic testing rather than drug administration, direct side effects are minimal and may include discomfort from sample collection. Indirect effects could arise from changes in medication regimens following test results.
ToPP-UP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-14 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Patient Treatment Satisfaction Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
ToPP-UP Trial Design
2Treatment groups
Experimental Treatment
Group I: Immediate panel-based pharmacogenetic genotypingExperimental Treatment1 Intervention
Subjects assigned to the immediate pharmacogenetic genotyping group will be tested and have their results both entered into their electronic health record as well as provided to them within 2-4 weeks from enrollment.
Group II: Delayed panel-based pharmacogenetic genotypingExperimental Treatment1 Intervention
Subjects assigned to delayed panel-based pharmacogenetic genotyping will be tested, but their results will not be released until after their participation in the study has ended (12 months after enrollment).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Panel-based pharmacogenetic genotyping
2021
N/A
~100
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,175 Total Patients Enrolled
National Human Genome Research Institute (NHGRI)NIH
263 Previous Clinical Trials
283,640 Total Patients Enrolled
Julio Duarte, PharmD, PhDPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
111 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on chronic kidney dialysis.I've had a medication change or new diagnosis treatable with medication in the last 8 months.I have had a stem cell or liver transplant from a donor.I have had genetic testing for medication response.I am older than 18 years.I can answer questions about my health and treatment.I am currently taking three or more prescribed medications.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate panel-based pharmacogenetic genotyping
- Group 2: Delayed panel-based pharmacogenetic genotyping
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available opportunities for individuals to join this trial?
"Clinicaltrials.gov reports that this particular medical trial is still recruiting volunteers. This study was initially posted on the 1st of August 2022 and saw its last update on the 5th of August 2022."
Answered by AI
How many individuals are eligible for this medical experiment?
"Indeed, research on clinicaltrials.gov affirms that this experiment is actively recruiting participants. The study was first uploaded to the website on August 1st 2022 and has been recently revised for accuracy as of August 5th 2022. As such, 492 individuals across a single location are needed in order to complete it successfully."
Answered by AI
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