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Studying The Effects of Pharmacogenomic (PGx) Testing on Drug Dosing in Cancer Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04541381
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : January 7, 2021
Information provided by (Responsible Party):
University of Chicago

Brief Summary:

Doctors leading this study hope to find out if giving study participants' genetic information to cancer care providers will help personalize chemotherapy dosing decisions and decrease common chemotherapy side effects. Doctors leading the study will collect genetic information from study participants using pharmacogenomic (PGx) testing/genotyping. Pharmacogenomics is the study of how the differences in our genes can affect our unique response to medications.

This is a randomized study, which means that participants in this study will be assigned to one of two different groups randomly (as if "by flip of a coin"): a "pharmacogenomics/PGx testing" group or "control group".

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Breast Cancer Head and Neck Cancer Other: Pharmacogenomics (PGx) Testing and Genomics Prescribing Information (GPS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: PhOCus: Implementation of Pharmacogenomic Testing in Oncology Care
Actual Study Start Date : August 14, 2020
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : October 1, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control Group (No PGx Test)
Participants assigned to the control group will not take a genotyping/PGx test during the start of treatment and will instead receive standard chemotherapy without their doctors receiving any genetic information based on the participants' PGx test results. Blood samples for participants in this group will be stored and tested for genotyping six months later after treatment (or earlier if the participant experiences side effects).
Experimental: Pharmacogenomics (PGx Testing) Group
Participants enrolled in the pharmacogenomics (PgX) testing group will give a blood sample for immediate genotyping/PGx testing. Once the results from these tests are in, cancer doctors caring for each participant will have immediate access to the participant's genetic test results and can make dosing decisions/changes to the participant's chemotherapy prescription based on genetic information found in their PGx test results.
Other: Pharmacogenomics (PGx) Testing and Genomics Prescribing Information (GPS)
A genotyping test and prescribing system designed to provide participant-specific dosing information to cancer care providers based on the participant's unique genetics/genomics.

Primary Outcome Measures :
  1. Number of Participants Who Receive Dose Modifications/Changes [ Time Frame: 8 months ]
    To determine the impact of potential PGx (pharmacogenomics testing) results on chemotherapy dosing during the first treatment cycle. Doctors leading the study will determine this by comparing how much each study participant's chemotherapy dosage changes (known as dose intensity deviation rates) during the first treatment cycle to dosage rates among a control group of participants who will receive standard chemotherapy treatment without any guidance based on PGx test results.

  2. Number of Participants Who Report Grade 3 Toxicities/Adverse Events [ Time Frame: 2 years ]
    To determine if giving doctors participant-specific dosing information based on PGx (pharmacogenomics) test results will affect how often study participants report negative side effects during treatment. The potential effect of this genetic information on drug toxicity will be measured by collecting data on the number of reported adverse events (negative side effects of CTCAE Grade 3 or higher ) among study participants.

Secondary Outcome Measures :
  1. Drug Dose Intensity [ Time Frame: 2 years. ]
    To determine if sharing PgX (pharmacogenomics) information from study participants has any impact on drug dose intensity. Researchers will determine this by reviewing chemotherapy orders and dosing information for each study participant during their treatment course.

  2. Progression Free Survival [ Time Frame: 2 years. ]
    To determine progression free survival (how long participants stay alive without their cancer getting worse) by tumor type and disease. Each participant's tumor response will be assessed based on re-staging scans and progress notes throughout the participants' course of treatment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Individuals who receive ongoing cancer care at the University of Chicago Medical Center and plan to receive fluoropyrimidine and/or irinotecan as part of therapy.
  • Subjects must be at least 18 years of age.

Exclusion Criteria:

  • Subjects who have previously been exposed to the planned chemotherapy agent at any time (fluoropyrimidine and/or irinotecan).
  • Subjects enrolled in an investigational trial which would preclude dose modifications of fluoropyrimidine and/or irinotecan chemotherapies.
  • Subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation.
  • Subjects with a history of or active blood cancer (e.g., leukemia).
  • Chronic kidney disease (as confirmed by clinical laboratory values) due to the risk of decreased drug excretion.
  • Liver dysfunction (confirmed by clinical laboratory values) due to the risk of decreased drug metabolism.
  • Inability to understand and give informed consent to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04541381

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Contact: Peter O'Donnell, MD (773) 702-4400
Contact: Natalie Reizine, MD (773) 702-4400

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United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Peter O'Donnell, MD    773-702-7564   
Contact: Natalie Reizine, MD    (773) 702-4400   
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Peter O'Donnell, MD University of Chicago
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Responsible Party: University of Chicago Identifier: NCT04541381    
Other Study ID Numbers: IRB20-0462
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases