Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Subject Lost-to-Follow-Up
研究概览
简要总结
The purpose of this study is to observe the routine clinical care of patients who have been diagnosed with breast cancer and have undergone Guardant360 testing.
详细描述
Patients who have been diagnosed with breast cancer and have undergone Guardant360 testing will be approached regarding participation in the study. After being informed about the study and potential risks, all patients providing informed consent and access to their medical records, will provide a list of their health care providers related to their cancer treatment. Data related to their routine clinical care will be abstracted from medical records.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 years of age and older) with a diagnosis of breast cancer
- •Guardant360 test results released to the patient's physician no less than 14 days prior to initial patient contact
- •Patient has previously provided contact information (either email or phone) to Guardant Health
- •Able and willing to complete the electronic informed consent process
- •Must have access to a computer terminal or personal computing device
- •Willingness to consent to the release of medical records
排除标准
- •Unable to understand English
结局指标
主要结局
Subject Lost-to-Follow-Up
时间窗: 18 months post Guardant360 testing
The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up The length of time from date of study consent to date subject exited study prematurely due being considered lost-to-follow-up (ex. lack of response following consent)
Overall Survival
时间窗: 18 months post Guardant360 testing
The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up Overall Survival is the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Progression Events
时间窗: 18 months post Guardant360 testing
The Primary Outcome measure is a composite endpoint of: overall survival, progression events, and subjects lost-to-follow-up Progression events (or progression-free survival) is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
次要结局
- Time to Next Treatment(18 months post Guardant360 testing)
- Rate of biomarker discovery(18 months post Guardant360 testing)
- Demographics(18 months post Guardant360 testing)
- Real-world Time to Tumor Progression(18 months post Guardant360 testing)
- Real-world Overall Survival(18 months post Guardant360 testing)