REFLECTION: A Clinical Practice Learning Program for Galleri®

NCT ID: NCT05205967

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

14633 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-23

Study Completion Date

2026-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Early Detection of Cancer Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients who received the Galleri® test.

MCED

Intervention Type OTHER

Multi-cancer early detection (MCED) test

SOC

Intervention Type OTHER

Standard of care cancer screening

Interventions

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MCED

Multi-cancer early detection (MCED) test

Intervention Type OTHER

SOC

Standard of care cancer screening

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GRAIL, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vincere Cancer Center

Scottsdale, Arizona, United States

Site Status

Providence

Burbank, California, United States

Site Status

Providence, St. Jude

Fullerton, California, United States

Site Status

Providence, Mission

Mission Viejo, California, United States

Site Status

Providence, Orange County

Orange, California, United States

Site Status

VA Miami Health Care System

Miami, Florida, United States

Site Status

James A. Haley Veterans Hospital (VA Tampa)

Tampa, Florida, United States

Site Status

Southeast Louisiana Veterans Health Care System (SLVHCS) (VA New Orleans)

New Orleans, Louisiana, United States

Site Status

Boston VA Research Institute (VA Boston)

Boston, Massachusetts, United States

Site Status

Providence

Portland, Oregon, United States

Site Status

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

Site Status

VA Wilkes Barre Medical Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Carolina Blood and Cancer Care Associate

Lancaster, South Carolina, United States

Site Status

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, United States

Site Status

VA Salt Lake City Health Care System (VASLCHCS)

Salt Lake City, Utah, United States

Site Status

WVU University Town Centre Family Medicine

Morgantown, West Virginia, United States

Site Status

Countries

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United States

References

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Kortlever TL, Ferlizza E, Lauriola M, Borrelli F, Porro A, Spaander MCW, Bossuyt PM, Ricciardiello L, Dekker E. Diagnostic Accuracy of an Add-On, Blood-Based Screening Test for Colorectal Cancer in Two Established Screening Programmes. Aliment Pharmacol Ther. 2025 Jun;61(12):1935-1943. doi: 10.1111/apt.70141. Epub 2025 Apr 10.

Reference Type DERIVED
PMID: 40207404 (View on PubMed)

Other Identifiers

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GRAIL-MA-001

Identifier Type: -

Identifier Source: org_study_id

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