Pharmacogenomics Testing in Directing the Optimal Use of Supportive Care Medications in Patients With Stage III-IV Cancer
Primary Purpose
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection
Genetic Testing
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
About this trial
This is an interventional screening trial for Anatomic Stage III Breast Cancer AJCC v8
Eligibility Criteria
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)
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Screening (pharmacogenomics testing)
Arm 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.
Outcomes
Primary Outcome Measures
Changes in symptoms, quality of life (QOL), and perceptions about pharmacogenomics (PGx) testing
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
Provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients
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.
Full Information
NCT ID
NCT04067960
First Posted
August 22, 2019
Last Updated
July 20, 2023
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04067960
Brief Title
Pharmacogenomics Testing in Directing the Optimal Use of Supportive Care Medications in Patients With Stage III-IV Cancer
Official Title
Precision Pharmacogenomics in Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
October 6, 2022 (Actual)
Study Completion Date
October 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Biliary Tract Carcinoma, Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Malignant Brain Neoplasm, Malignant Genitourinary System Neoplasm, Malignant Solid Neoplasm, Pancreatobiliary Carcinoma, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Prognostic Stage IV Breast Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIA Ovarian Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIB Ovarian Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVA Ovarian Cancer AJCC v8, Stage IVA Pancreatic Cancer, Stage IVA Prostate Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVB Ovarian Cancer AJCC v8, Stage IVB Pancreatic Cancer, Stage IVB Prostate Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8
7. Study Design
Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Screening (pharmacogenomics testing)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo collection of saliva
Intervention Type
Other
Intervention Name(s)
Genetic Testing
Other Intervention Name(s)
genetic analysis, Genetic Examination, Genetic Test
Intervention Description
Undergo pharmacogenomics testing
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Changes in symptoms, quality of life (QOL), and perceptions about pharmacogenomics (PGx) testing
Description
Patient survey responses will be compared across administration time points to look for changes in symptoms, QOL, and perceptions about PGx testing.
Time Frame
Baseline up to 3 months post consent
Secondary Outcome Measure Information:
Title
Provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients
Description
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.
Time Frame
Up to 3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niloy J Samadder
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacogenomics Testing in Directing the Optimal Use of Supportive Care Medications in Patients With Stage III-IV Cancer
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