Studying The Effects of Pharmacogenomic (PGx) Testing on Drug Dosing in Cancer Care

  • Interventional
  • Recruiting
  • NCT04541381
Eligibility Details Visit Clinicaltrials.gov

PhOCus: Implementation of Pharmacogenomic Testing in Oncology Care

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".

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Individuals who receive ongoing cancer care at the University of Chicago Medical Center and plan to receive fluoropyrimidine and/or irinotecan as part of therapy.

         - Subjects must be at least 18 years of age.

        Exclusion Criteria:

         - 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 confirmed by clinical laboratory values) due to the risk of decreased drug excretion.

         - Liver dysfunction (confirmed by clinical laboratory values) due to the risk of decreased drug metabolism.

         - Inability to understand and give informed consent to participate.

At a Glance

National Government IDNCT04541381

IRB#IRB20-0462

Lead SponsorUniversity of Chicago

Lead PhysicianPeter H. O'Donnell

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting