The PhOCus Trial: Implementation of Pharmacogenomic Testing in Oncology Care

Plain-language summary

This study evaluates the use of clinical decision support based on pharmacogenomic test results in cancer patients. It enrolls adult oncology patients for whom treatment with a fluoropyrimidine and/or irinotecan is planned. This is a study without an assigned phase and is still recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

University of Chicago

Intervention

Availability of clinical decision support based on pharmacogenomic results.

Start date

2/7/2022

Estimated completion

3/31/2028

Countries

United States

Related genes

Locations

• Chicago, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria Adult patients receiving oncology care at The University of Chicago Medical Center, and for whom treatment with a fluoropyrimidine and/or irinotecan is planned are eligible.

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 Criteria

1. Subjects who have previously been exposed to the planned chemotherapy agent at any time (fluoropyrimidine and/or irinotecan).
2. Subjects enrolled in an investigational trial which would preclude dose modifications of fluoropyrimidine and/or irinotecan chemotherapies.
3. Subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation.
4. Subjects with a history of or active blood cancer (e.g., leukemia).
5. Chronic kidney disease, as defined by glomerular filtration rate (GFR) \< 30/mL/min/1.73m2, due to the risk of decreased drug excretion.
6. 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).
7. 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.
8. Inability to understand and give informed consent to participate.