NCT05673018招募中不适用
REACH Study: Galleri® in the Medicare Population.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- GRAIL, Inc.
- 入组人数
- 50,000
- 试验地点
- 84
- 主要终点
- Incidence rates of stage IV cancers
研究概览
简要总结
This multi-center comparative prospective cohort study is designed to assess the real world clinical impact, including safety and test performance, of Galleri®, a blood-based multi-cancer early detection (MCED) test. The study will seek enrollment that is representative of the Medicare population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Galleri + UC (Galleri-Tested Arm):
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Aged ≥50 years with Medicare coverage, including Traditional Medicare (Part A & B or Dual Eligibles) or Medicare Advantage.
- •Capable of giving informed consent that is legally effective (consent provided by a legally authorized representative is not permitted in this protocol).
- •For UC (Not Galleri-tested Arm):
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Aged ≥ 50 years with Medicare coverage, including Traditional Medicare (Part A & B or Dual Eligibles) or Medicare Advantage.
- •Have had ≥ 1 UC visit
排除标准
- •For Galleri + UC (Galleri-Tested Arm):
- •Evidence of having had a previous MCED test (including but not limited to the Galleri test, e.g. CancerSeek, PanSeer). Participation in a study such as GRAIL's STRIVE study where results were not returned is not an exclusion criterion.
- •Undergoing clinical evaluation for suspicion of cancer within 6 months prior to enrollment. Personal history of hematologic malignancy and/or invasive solid tumor (excluding non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin):
- •Diagnosed ≤3 years before expected enrollment date and/or
- •Diagnosed >3 years before expected enrollment date and never treated and/or
- •Currently undergoing active cancer management (not including adjuvant hormone therapy for breast or prostate cancer).
- •Current pregnancy.
- •Individuals who are currently inpatients at a participating site.
- •Individuals who are not willing or able to comply with the protocol procedures.
- •Individuals who are not currently registered patients at a participating center.
- •Previous or current employees or contractors of GRAIL.
- •For UC (Not Galleri-tested Arm):
- •Evidence of having had a previous MCED test (including but not limited to the Galleri test, eg.CancerSeek, PanSeer). Participation in a study such as GRAIL's STRIVE study where results were not returned is not an exclusion criterion.
- •Undergoing clinical evaluation for suspicion of cancer.
- •Personal history of hematologic malignancy and/or invasive solid tumor (not including non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin):
- •Diagnosed ≤3 years before expected enrollment date and/or
- •Diagnosed >3 years before expected enrollment date and never treated and/or
- •Currently undergoing active cancer management (not including adjuvant hormone therapy for breast or prostate cancer).
- •Current pregnancy.
- •Individuals who are currently inpatients at a participating site.
研究组 & 干预措施
(Galleri + UC)
Experimental
Medicare beneficiaries who receive the Galleri test plus usual care (Galleri + UC).
干预措施: Multi-Cancer Early Detection Test (Galleri®) (Device)
(UC) alone
No Intervention
Passively-enrolled Contemporaneous Comparator Arm of Medicare beneficiaries who receive usual care (UC) alone.
结局指标
主要结局
Incidence rates of stage IV cancers
时间窗: Up to 3 Years
次要结局
- Safety: Number and type of invasive procedures performed to evaluate a cancer signal detected test result(Up to 3 Years)
- Adherence to guideline-recommended cancer screening in the Galleri+UC arm and UC arm over time(Up to 3 Years)
- Healthcare resource utilization associated with cancer diagnostic evaluations in the Galleri+UC arm and UC arm(Up to 3 Years)
- Galleri test performance in the Galleri + UC arm(Up to 3 Years)
研究者
研究点 (84)
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