CancerNCT05166694
Evaluating Personalized Therapeutics Clinic (PTC) on Drug-Drug Interactions and Drug-Gene Interactions
A study testing Drug-Drug Interaction Profile and Drug-Gene Interaction Profile in people with Cancer and Advanced Cancer, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Advanced Cancer, Advanced Solid Tumor
- What is being tested?
- Drug-Drug Interaction Profile and Drug-Gene Interaction Profile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2022to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medicine
Chicago, Illinois, 60637
Andre Hall, 773-834-0936, andrehall@bsd.uchicago.edu
Mark Ratain
About this study
Official title: Evaluating the Effectiveness of a Personalized Therapeutics Clinic (PTC) Intervention on Drug-Drug Interactions (DDIs) and Drug-Gene Interactions (DGIs)
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.
- Being tested
- Drug-Drug Interaction Profile, Drug-Gene Interaction Profile, Standard of Care
- Keywords
- tumor, advanced cancer, advanced solid tumor, cancer medication, prescriptions, inhibitor drug, inducer drug
- Medical subject headings
- Neoplasms, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-Drug Interaction ProfileOther
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 ProfileOther
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 CareOther
The standard treatment and prescribing for the participant's specific type of cancer.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Prescribing Based on Information From Both Drug-Drug and Drug-Gene Profiles | Experimental | 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. Receives: Other: Drug-Drug Interaction Profile; Other: Drug-Gene Interaction Profile |
| Group 2: Prescribing Based ONLY on Information From Drug-Drug Interaction Profiles | Experimental | 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. Receives: Other: Drug-Drug Interaction Profile |
| Group 3: Prescribing Not Based on ANY Profile Information (Drug-Drug or Drug-Gene Interactions) | Experimental | 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (7)
Participants At High-Risk for Drug-Drug and Drug-Gene Interactions
Reported as a percentage of total hospitalized participants
Measured: 9 months
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.
Measured: 9 months
Rate of Hospitalizations
The rate of hospitalizations among participants in all three arms as assessed by study notes/clinical record.
Measured: 9 months
Rate of Emergency Department Visits
Rate of emergency department visits among participants in all three arms as assessed by study notes/clinical record.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start30 Nov 2022
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Ratain, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166694
- Sponsor's protocol ID
- IRB21-1527
- Status last verified
- Mar 2026
- First submitted
- 8 Dec 2021
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Personalized Therapeutics Clinic (PTC) Intervention on Drug-Drug Interactions (DDIs) and Drug-Gene Interactions (DGIs)
- ClinicalTrials.gov ID
- NCT05166694
- Acronym / sponsor ID
- IRB21-1527
- Keywords
- tumor, advanced cancer, advanced solid tumor, cancer medication, prescriptions, inhibitor drug, inducer drug
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Prescribing Based on Information From Both Drug-Drug and Drug-Gene Profiles | Experimental | Other: Drug-Drug Interaction Profile, Other: Drug-Gene Interaction ProfileGroup 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 2: Prescribing Based ONLY on Information From Drug-Drug Interaction Profiles | Experimental | Other: Drug-Drug Interaction ProfileGroup 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 3: Prescribing Not Based on ANY Profile Information (Drug-Drug or Drug-Gene Interactions) | Experimental | Other: Standard of CareGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-Drug Interaction ProfileA profile based on genetic testing that shows information about how the participant's medications they are taking interact with each other. | Other | 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 |
| Drug-Gene Interaction ProfileA profile based on genetic testing that shows information about how the participant's genes interact with/respond to certain medications they are taking. | Other | Group 1: Prescribing Based on Information From Both Drug-Drug and Drug-Gene Profiles |
| Standard of CareThe standard treatment and prescribing for the participant's specific type of cancer. | Other | Group 3: Prescribing Not Based on ANY Profile Information (Drug-Drug or Drug-Gene Interactions) |
Primary outcome
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.
7 secondary outcomes
Participants At High-Risk for Drug-Drug and Drug-Gene Interactions
Time frame: 9 months
Strategy to Implement at Personalize Therapeutic Clinic (PTC) at Specific Sites Based on Available Mediators (PTC Partners)
Time frame: 9 months
Rate of Hospitalizations
Time frame: 9 months
Rate of Emergency Department Visits
Time frame: 9 months
Rate of Reported Adverse Events as Assessed by Clinical Records
Time frame: 9 months
Changes in Participant Knowledge and Perceptions of the Personalized Therapeutic Clinic (PTC) as Assessed by Survey Results
Time frame: 9 months
Changes in provider knowledge and perceptions of the Personalized Therapeutic Clinics (PTC) Assessed by Survey Results
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Ratain, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-Drug Interaction Profile and Drug-Gene Interaction Profile in people with Cancer and Advanced Cancer, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andre Hall ((773)834-0936, andrehall@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rate of Drug-Drug Interactions and Drug-Gene Interactions Among Participants (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.