NCT05205967

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14,633

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
1 country

16 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Aug 2021Oct 2026

Study Start

First participant enrolled

August 23, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Expected
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

4.1 years

First QC Date

September 14, 2021

Last Update Submit

November 20, 2025

Conditions

Early Detection of CancerCancer

Keywords

Multi-cancer early detectionCancer screeningCirculating cell-free tumor DNA

Outcome Measures

Primary Outcomes (1)

  • To describe signal detection and cancer detection within and across sites among participants who opt to receive Galleri® in a real world setting.

    Up to 12 Months

Secondary Outcomes (2)

  • Galleri®: To assess the feasibility and acceptability of Galleri® from the perspective of participants and patient-reported outcomes (PROs) in a real-world setting.

    Up to 12 Months

  • HCRU: To assess healthcare resource utilization (HCRU) associated with cancer diagnostic workups for participants with signal detected Galleri® test results.

    Up to 12 Months

Study Arms (1)

Patients who received the Galleri® test.

Other: MCEDOther: SOC

Interventions

MCEDOTHER

Multi-cancer early detection (MCED) test

Patients who received the Galleri® test.
SOCOTHER

Standard of care cancer screening

Patients who received the Galleri® test.

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Vincere Cancer Center

Scottsdale, Arizona, 85260, United States

Location

Providence

Burbank, California, 91505, United States

Location

Providence, St. Jude

Fullerton, California, 92835, United States

Location

Providence, Mission

Mission Viejo, California, 92691, United States

Location

Providence, Orange County

Orange, California, 92868, United States

Location

VA Miami Health Care System

Miami, Florida, 33125, United States

Location

James A. Haley Veterans Hospital (VA Tampa)

Tampa, Florida, 33612, United States

Location

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

New Orleans, Louisiana, 70119, United States

Location

Boston VA Research Institute (VA Boston)

Boston, Massachusetts, 02111-1750, United States

Location

Providence

Portland, Oregon, 97213, United States

Location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

VA Wilkes Barre Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Carolina Blood and Cancer Care Associate

Lancaster, South Carolina, 29720, United States

Location

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, 29732, United States

Location

VA Salt Lake City Health Care System (VASLCHCS)

Salt Lake City, Utah, 84148, United States

Location

WVU University Town Centre Family Medicine

Morgantown, West Virginia, 26501, United States

Location

Related Publications (1)

  • 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.

    PMID: 40207404DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2021

First Posted

January 25, 2022

Study Start

August 23, 2021

Primary Completion

September 30, 2025

Study Completion (Estimated)

October 30, 2026

Last Updated

November 26, 2025

Record last verified: 2025-11

Locations

US(16)