Clinical trial NCT04067960: Pharmacogenomics Testing in the Optimal Use of Supportive Care Medications in Stage III-IV Cancer
Official title: Precision Pharmacogenomics in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 197
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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)

Primary outcomes:
measure: Changes in symptoms, quality of life (QOL), and perceptions about pharmacogenomics (PGx) testing
timeFrame: Baseline up to 3 months post consent
Secondary outcomes:
measure: Provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Jewel Samadder, M.D.
role: PRINCIPAL_INVESTIGATOR
References: