Pharmacogenomics Testing in the Optimal Use of Supportive Care Medications in Stage III-IV Cancer

Mayo Clinic

Status and phase: Completed; Early Phase 1

Conditions: Pathologic Stage IIIB Cutaneous Melanoma AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IIIA Ovarian Cancer AJCC v8; Stage IVA Pancreatic Cancer; Stage IIIA Colorectal Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Malignant Genitourinary System Neoplasm; Malignant Brain Neoplasm; Stage IVB Ovarian Cancer AJCC v8; Stage IVA Ovarian Cancer AJCC v8; Pathologic Stage IV Cutaneous Melanoma AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8; Stage IIIC Ovarian Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Clinical Stage III Cutaneous Melanoma AJCC v8; Stage IIIB Ovarian Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Pathologic Stage IIIA Cutaneous Melanoma AJCC v8; Pathologic Stage III Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Stage IVB Pancreatic Cancer; Malignant Solid Neoplasm; Stage IVB Colorectal Cancer AJCC v8; Pancreatobiliary Carcinoma; Anatomic Stage III Breast Cancer AJCC v8; Biliary Tract Carcinoma; Stage III Colorectal Cancer AJCC v8

Treatments: Other: Genetic Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Biospecimen Collection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04067960

NCI-2019-04725 (Registry Identifier)

19-002006 (Other Identifier)

Details and patient eligibility

About

This early phase I trial studies how well a genetic test called pharmacogenomics works in directing the optimal use of supportive care medications in patients with stage III-IV cancer. Pharmacogenomics is the study of how genes may affect the body's response to and interaction with some prescription medications. Genes, which are inherited from parents, carry information that determines things such as eye color and blood type. Genes can also influence how patients process and respond to medications. Depending on the genetic makeup, some medications may work faster or slower or produce more or fewer side effects. Pharmacogenomics testing may help doctors learn more about how patients break down and process specific medications based on their genes and improve the quality of life of cancer patients receiving clinical care.

Full description

PRIMARY OBJECTIVES:

I. Evaluate patient perceptions surrounding their quality of life (QOL) prior to pharmacogenomics (PGx) testing and 3 months post PGx testing.

II. Understand the clinical utility/relevancy of PGx testing in cancer patients at Mayo Clinic Arizona from the viewpoint of their providers.

OUTLINE:

Patients undergo one-time collection of saliva sample for pharmacogenomics testing. Patients also complete quality of life assessment at baseline and at 3 months after pharmacogenomics testing.

After completion of study, patients are followed for up to 1 year.

Enrollment: 197 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient enrolled to Mayo Clinic IRB: 18-000326
• Patients with stage 3 or 4 breast, colorectal, prostate/genitourinary (GU), pancreato-biliary, brain, melanoma, and ovarian cancer
• Individuals have agreed to participate and signed the study informed consent form

Exclusion criteria

• Patients with cancer types other than the ones mentioned above
• Patient with psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
• Previous PGx testing with results available within Mayo Clinic electronic medical record (EMR)

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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197 participants in 1 patient group

Screening (pharmacogenomics testing)

Experimental group

Description:

Patients undergo one-time collection of saliva sample for pharmacogenomics testing. Patients also complete quality of life assessment at baseline and at 3 months after pharmacogenomics testing.

Treatment:

Other: Questionnaire Administration

Procedure: Biospecimen Collection

Other: Quality-of-Life Assessment

Other: Genetic Testing