Studying The Effects of Pharmacogenomic (PGx) Testing on Drug Dosing in Cancer Care
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|ClinicalTrials.gov Identifier: NCT04541381|
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : January 7, 2021
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT04541381
|Contact: Peter O'Donnell, MD||(773) email@example.com|
|Contact: Natalie Reizine, MD||(773) 702-4400||Natalie.Reizine@uchospitals.edu|
|United States, Illinois|
|University of Chicago Medical Center||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Peter O'Donnell, MD 773-702-7564 firstname.lastname@example.org|
|Contact: Natalie Reizine, MD (773) 702-4400 Natalie.Reizine@uchospitals.edu|
|Principal Investigator:||Peter O'Donnell, MD||University of Chicago|