RecruitingNot ApplicableNCT05673018
Galleri® in the Medicare Population.
REACH Study: Galleri® in the Medicare Population.
Sponsor
GRAIL, Inc.
Enrollment
50,000 participants
Start Date
Jul 12, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 50 Years
Inclusion Criteria8
- 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
Exclusion Criteria20
- 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.
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Interventions
DEVICEMulti-Cancer Early Detection Test (Galleri®)
Blood collection and multi-cancer early detection testing with return of results.
Locations(47)
View Full Details on ClinicalTrials.gov
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NCT05673018
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