Galleri® Test for Early Cancer Detection in Medicare Patients
Galleri® in the Medicare Population.
Recruiting
N/AInterventional Study
Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 and older
Sex
Any
Study type
Interventional
Purpose
Screening
Participants needed
50,000 (estimated)
Sponsor
GRAIL, Inc. · Industry
Who this trial is looking for
This trial is looking for people aged 50 and older who have Medicare coverage. Participants will help assess the Galleri® blood test for early cancer detection and its safety.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 50 years old
I have Medicare coverage
I can give my own consent
You may not be able to join if
I have had a previous multi-cancer early detection test
I am being evaluated for cancer suspicion
I have a personal history of certain cancers diagnosed recently
I am currently pregnant
I am an inpatient at a participating site
I cannot follow the study rules
I am not a registered patient at a participating center
I have worked for GRAIL before
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
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…
Inclusion Criteria:
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 Criteria:
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):
1. Diagnosed ≤3 years before expected enrollment date and/or
2. Diagnosed \>3 years before expected enrollment date and never treated and/or
3. 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):
1. Diagnosed ≤3 years before expected enrollment date and/or
2. Diagnosed \>3 years before expected enrollment date and never treated and/or
3. 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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