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

Early Phase 1

Completed

• Conditions: Biliary Tract Carcinoma; Pathologic Stage IIIA Cutaneous Melanoma AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8
• Interventions: Procedure: Biospecimen Collection; Other: Genetic Testing; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT04067960
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-06-06
• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-28
• Primary Completion: 2022-10-06
• Study Completion: 2022-10-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Screening (pharmacogenomics testing)	Genetic Testing	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.
Screening (pharmacogenomics testing)	Quality-of-Life Assessment	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.
Screening (pharmacogenomics testing)	Biospecimen Collection	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.
Screening (pharmacogenomics testing)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Changes in symptoms, quality of life (QOL), and perceptions about pharmacogenomics (PGx) testing	Baseline up to 3 months post consent	Patient survey responses will be compared across administration time points to look for changes in symptoms, QOL, and perceptions about PGx testing.

Secondary Outcome Measures

Name	Time	Method
Provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients	Up to 3 months	Will qualitatively assess provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients via the provider survey. Provider survey responses will be examined to determine the range of perceptions and experiences associated with PGx testing and result reporting for patient tests. Descriptive statistics will be used to report provider survey results.

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States