REFLECTION: A Clinical Practice Learning Program for Galleri®

November 20, 2025 updated by: GRAIL, Inc.

REFLECTION: Real World Evidence for Learnings in Early Cancer Detection, a Clinical Practice Learning Program for Galleri®

REFLECTION is a multi-center, prospective, non-interventional, cohort study that will enroll approximately 14,000 individuals who have opted to be screened with Galleri®, a blood-based, multi-cancer early detection (MCED) test in routine clinical settings. The purpose of the study is to understand the real-world experience of Galleri® in clinical settings.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

14633

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Vincere Cancer Center
    • California
      • Burbank, California, United States, 91505
        • Providence
      • Fullerton, California, United States, 92835
        • Providence, St. Jude
      • Mission Viejo, California, United States, 92691
        • Providence, Mission
      • Orange, California, United States, 92868
        • Providence, Orange County
    • Florida
      • Miami, Florida, United States, 33125
        • VA Miami Health Care System
      • Tampa, Florida, United States, 33612
        • James A. Haley Veterans Hospital (VA Tampa)
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Southeast Louisiana Veterans Health Care System (SLVHCS) (VA New Orleans)
    • Massachusetts
      • Boston, Massachusetts, United States, 02111-1750
        • Boston VA Research Institute (VA Boston)
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • VA Wilkes Barre Medical Center
    • South Carolina
      • Lancaster, South Carolina, United States, 29720
        • Carolina Blood and Cancer Care Associate
      • Rock Hill, South Carolina, United States, 29732
        • Carolina Blood and Cancer Care Associates
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • VA Salt Lake City Health Care System (VASLCHCS)
    • West Virginia
      • Morgantown, West Virginia, United States, 26501
        • WVU University Town Centre Family Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will enroll approximately 14,000 participants who meet the defined eligibility criteria.

Description

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

  • Participant has the ability to understand and the willingness to sign a written informed consent form (ICF);
  • Participant is at least 22 years old at the time of consent;
  • A provider or their designee has ordered the Galleri® test; and
  • Participant has the ability to comprehend the participant questionnaires.

Exclusion Criteria:

  • There are no exclusions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who received the Galleri® test.
Other: MCED
Multi-cancer early detection (MCED) test
Other: SOC
Standard of care cancer screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To describe signal detection and cancer detection within and across sites among participants who opt to receive Galleri® in a real world setting.
Time Frame: Up to 12 Months
Up to 12 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Galleri®: To assess the feasibility and acceptability of Galleri® from the perspective of participants and patient-reported outcomes (PROs) in a real-world setting.
Time Frame: Up to 12 Months
Up to 12 Months
HCRU: To assess healthcare resource utilization (HCRU) associated with cancer diagnostic workups for participants with signal detected Galleri® test results.
Time Frame: Up to 12 Months
Up to 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GRAIL, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2021

Primary Completion (Actual)

September 30, 2025

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRAIL-MA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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