Home › Trials › NCT05673018

Assessing a blood test for early cancer detection in Medicare patients

REACH Study: Galleri® in the Medicare Population.

Not applicable Interventional GRAIL, Inc. · NCT05673018

This study is testing a new blood test called Galleri to see if it can help detect cancer early in people aged 50 and older who are on Medicare.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment50000 (estimated)
Ages50 Years and up
SexAll
SponsorGRAIL, Inc. Industry-sponsored
Locations47 sites (Auburn, California and 46 other locations)
Trial IDNCT05673018 on ClinicalTrials.gov

What this trial studies

This multi-center comparative prospective cohort study evaluates the clinical impact, safety, and performance of the Galleri® test, a blood-based multi-cancer early detection tool. The study aims to enroll participants aged 50 and older with Medicare coverage, including a focus on under-represented minority populations. Participants will be divided into two groups: those receiving the Galleri test and those receiving usual care. The study seeks to gather real-world data on the effectiveness of this innovative screening method.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older with Medicare coverage who are eligible for the Galleri test.

Not a fit: Patients with a personal history of invasive solid tumors or those currently undergoing evaluation for cancer symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier cancer detection, improving treatment outcomes for patients.

How similar studies have performed: Other studies have shown promise with similar multi-cancer early detection approaches, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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 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.

Where this trial is running

Auburn, California and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions CancerctDNA, Circulating tumor DNA, Screening, Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.