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

Inclusion Criteria1

Individuals of all genders, races and ethnic groups are eligible for this trial. There is no bias towards race, sex, or gender in the clinical trial outlined.

Exclusion Criteria8

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 defined by glomerular filtration rate (GFR) \< 30/mL/min/1.73m2, due to the risk of decreased drug excretion.
Liver dysfunction, as defined by the following laboratory values, due to the risk of decreased drug metabolism: Total bilirubin more than 1.5 mg/dL, aspartate Aminotransferase (AST) and alanine transaminase (ALT) more than 2.5 X upper limit of normal\*. (\*AST and ALT more than 5 X upper limit of normal if hepatic metastases are present).
Subjects who have previously or are currently enrolled in another institutional pharmacogenomic genotyping study, or are known to have previously undergone pharmacogenomic genotyping for the gene(s) of interest via another commercial or other means.
Inability to understand and give informed consent to participate.

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.