Precision Pharmacogenomics in Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 197
- 试验地点
- 1
- 主要终点
- Changes in symptoms, quality of life (QOL), and perceptions about pharmacogenomics (PGx) testing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Screening (pharmacogenomics 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.
干预措施: Biospecimen Collection (Procedure)
Screening (pharmacogenomics 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.
干预措施: Genetic Testing (Other)
Screening (pharmacogenomics 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.
干预措施: Quality-of-Life Assessment (Other)
Screening (pharmacogenomics 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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Changes in symptoms, quality of life (QOL), and perceptions about pharmacogenomics (PGx) testing
时间窗: 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.
次要结局
- Provider opinions surrounding the clinical utility/relevancy of PGx testing in cancer patients(Up to 3 months)