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New treatment option for Cancer
Official title Galleri® in the Medicare Population.
ClinicalTrials.gov ID: NCT05673018
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Aged ≥ 50 years with Medicare coverage, including Traditional Medicare (Part A \& B or Dual Eligibles) or Medicare Advantage.
- Have had ≥ 1 UC visit
You likely can't join if
- 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...
- Undergoing clinical evaluation for suspicion of cancer within 6 months prior to enrollment. Personal history of hematologic malignancy and/or...
- 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).
See the full eligibility 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...
- Aged ≥ 50 years with Medicare coverage, including Traditional Medicare (Part A \& B or Dual Eligibles) or Medicare Advantage.
- Have had ≥ 1 UC visit
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fort Smith, Arkansas, United States
- Auburn, California, United States
- Davis, California, United States
- Elk Grove, California, United States
- Fountain Valley, California, United States
- Laguna Hills, California, United States
- Long Beach, California, United States
- Modesto, California, United States
- Palo Alto, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Santa Barbara, California, United States
- Santa Cruz, California, United States
- Santa Rosa, California, United States
- Sunnyvale, California, United States
- Vallejo, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
+ 26 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Smith, Arkansas, United States; Auburn, California, United States; Davis, California, United States; Elk Grove, California, United States; Fountain Valley, California, United States; Laguna Hills, California, United States and 40 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.