The Galleri® Community Research Program
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- GRAIL, Inc.
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Quality of data retrieved from participants who have received the Galleri test
研究概览
简要总结
GRAIL, the company that developed the Galleri test and is sponsoring this study, would like to learn more from individuals who have received the Galleri multi-cancer early detection test.
The purpose of this study is to understand how health information can be accurately collected from the medical records of individuals who have received the Galleri test in a real world setting. The collected information may include relevant medical and cancer history, diagnostic test results, including the Galleri test result. This will help GRAIL build a future larger study for individuals who have taken the Galleri test. This future study is important for understanding patient journeys after a Galleri test (including any diagnostic testing done and any diagnoses made), for improving the Galleri test, and to contribute to other research on cancer screening.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have received the Galleri test prescribed by a provider per clinical care
- •Capable of giving signed and legally effective informed consent. Consent provided by a legally authorized representative is not permitted in this protocol.
- •Have signed HIPAA authorization(s)* form for their medical records to be released and used for this study.
排除标准
- •Patients are excluded from the study if the patient is a GRAIL employee or contractor.
- •Patients who have received the Galleri test in a GRAIL-sponsored research setting (i.e., clinical trial) are excluded.
结局指标
主要结局
Quality of data retrieved from participants who have received the Galleri test
时间窗: From enrollment to the the end of study (12 month study participation period), data will be retrieved and assessed for this measure.
Data quality is measured by data completeness and accuracy of key cancer outcome data elements retrieved from medical records for confirmed cancer cases of participants who received the Galleri test.
次要结局
- Data retrieval methods will be described.(From enrollment to the the end of study (12 month study participation period), data will be retrieved and assessed for this measure.)
- Describe the process of recruiting and consenting patients, and the retrieval of records in a narrative summary.(From enrollment to the the end of study (12 month study participation period), data will be retrieved and assessed for this measure.)