The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care
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|ClinicalTrials.gov Identifier: NCT04541381|
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : October 24, 2022
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 pharmacogenomics/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 randomly assigned (as if "by flip of a coin") to one of two different groups: a "pharmacogenomics group" or "control group".
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Cancer Head and Neck Cancer Dihydropyrimidine Dehydrogenase Deficiency UGT1A1 Gene Mutation Breast Cancer||Other: Availability of clinical decision support based on pharmacogenomic results.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||860 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care|
|Actual Study Start Date :||February 7, 2022|
|Estimated Primary Completion Date :||October 1, 2027|
|Estimated Study Completion Date :||March 31, 2028|
No Intervention: Control Group
Participants assigned to the control group will receive standard chemotherapy without their doctors receiving any genetic information based on the participants' pharmacogenetic results. DNA (Deoxyribonucleic acid) 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 Group
Participants enrolled in the pharmacogenomics group will give a DNA (deoxyribonucleic acid) sample for immediate pharmacogenomic genotyping. Once the genotyping results are in, cancer doctors caring for each participant will have immediate access to clinical decision support based on the participant's genetic results and can make dosing decisions/changes to the participant's chemotherapy prescription.
Other: Availability of clinical decision support based on pharmacogenomic results.
Availability of clinical decision support based on pharmacogenomic results. These results are designed to provide specific dosing information based on the participant's unique genetics/genomics.
- Dose Deviation Rate (Co-Primary Endpoint) [ Time Frame: 15 months ]To assess the impact of prospective pharmacogenomic testing on dose intensity deviation rate of chemotherapy during the 1st treatment cycle, comparing control vs. pharmacogenomics-guided arms.
- Grade 3 or Higher Toxicity (Co-Primary Endpoint) [ Time Frame: 5 years ]To determine the degree to which providing oncologists with comprehensive pharmacogenomic information impacts the incidence of Grade 3 or worse toxicities in subjects receiving chemotherapy. Toxicities will be assessed by Common Terminology Criteria for Adverse Events version 5.
- Cumulative Chemotherapy Dose Intensity [ Time Frame: 5 years. ]Cumulative drug dose intensity received (function of dose and frequency of drug administration).
- Response Rate [ Time Frame: 5 years. ]Anti-cancer tumor response based on radiographic assessment (complete response, partial response, stable disease, progressive disease), by tumor type and disease setting.
- Progression free survival (PFS) [ Time Frame: 5 years ]Progression free survival (PFS) by tumor type and disease setting.
- Overall Survival [ Time Frame: 5 years ]Overall survival (OS) by tumor type and disease setting.
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 H. O'Donnell, MDfirstname.lastname@example.org|
|United States, Illinois|
|University of Chicago Medical Center||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Peter H. O'Donnell, MD 773-834-0936 email@example.com|
|Principal Investigator:||Peter H. O'Donnell, MD||University of Chicago|