NCT05205967进行中（未招募）不适用
REFLECTION: Real World Evidence for Learnings in Early Cancer Detection, a Clinical Practice Learning Program for Galleri®
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GRAIL, Inc.
- 入组人数
- 14,633
- 试验地点
- 15
- 主要终点
- To describe signal detection and cancer detection within and across sites among participants who opt to receive Galleri® in a real world setting.
研究概览
简要总结
REFLECTION is a multi-center, prospective, non-interventional, cohort study that will enroll approximately 14,000 individuals who have opted to be screened with Galleri®, a blood-based, multi-cancer early detection (MCED) test in routine clinical settings. The purpose of the study is to understand the real-world experience of Galleri® in clinical settings.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Participant has the ability to understand and the willingness to sign a written informed consent form (ICF);
- •Participant is at least 22 years old at the time of consent;
- •A provider or their designee has ordered the Galleri® test; and
- •Participant has the ability to comprehend the participant questionnaires.
排除标准
- •There are no exclusions
结局指标
主要结局
To describe signal detection and cancer detection within and across sites among participants who opt to receive Galleri® in a real world setting.
时间窗: Up to 12 Months
次要结局
- Galleri®: To assess the feasibility and acceptability of Galleri® from the perspective of participants and patient-reported outcomes (PROs) in a real-world setting.(Up to 12 Months)
- HCRU: To assess healthcare resource utilization (HCRU) associated with cancer diagnostic workups for participants with signal detected Galleri® test results.(Up to 12 Months)
研究者
研究点 (15)
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