RecruitingNot ApplicableNCT04541381

The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care

Sponsor

University of Chicago

Enrollment

860 participants

Start Date

Feb 7, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Head and Neck Cancer Gastrointestinal Cancer Dihydropyrimidine Dehydrogenase Deficiency UGT1A1 Gene Mutation

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 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".

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a patient's genetic profile (pharmacogenomics) to personalize the dose of two common chemotherapy drugs — fluoropyrimidine (like 5-FU or capecitabine) and irinotecan — can reduce side effects and improve outcomes for cancer patients. **You may be eligible if...** - You are an adult receiving cancer treatment at the University of Chicago Medical Center - Your oncologist plans to treat you with a fluoropyrimidine and/or irinotecan - You have NOT previously been treated with these specific chemotherapy drugs **You may NOT be eligible if...** - You have previously received the planned chemotherapy agent - You are enrolled in a clinical trial that prohibits dose changes to these drugs - You have had or are being considered for a bone marrow, liver, or kidney transplant - You have a history of a condition that affects how these drugs are processed in your body Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAvailability 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.