REFLECTION: A Clinical Practice Learning Program for Galleri®

Recruiting

• Conditions: Cancer; Early Detection of Cancer
• Interventions: Other: MCED; Other: SOC

• Registration Number: NCT05205967
• Lead Sponsor: GRAIL, Inc.

Brief Summary

REFLECTION is a multi-center, prospective, non-interventional, cohort study that will enroll approximately 17,000 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

Not available

Study Timeline

• Study Start: 2021-08-23
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2025-06-23
• Study Completion: 2026-08-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 17000

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.

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Exclusion Criteria

• There are no exclusions

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who received the Galleri® test.	MCED	-
Patients who received the Galleri® test.	SOC	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (16)

WVU University Town Centre Family Medicine; 🇺🇸 Morgantown, West Virginia, United States

Vincere Cancer Center; 🇺🇸 Scottsdale, Arizona, United States

Providence, Mission; 🇺🇸 Mission Viejo, California, United States

Providence, St. Jude; 🇺🇸 Fullerton, California, United States

Providence, Orange County; 🇺🇸 Orange, California, United States

St. Helena Hospital (Adventist Health); 🇺🇸 Saint Helena, California, United States

VA Pittsburgh Healthcare System; 🇺🇸 Pittsburgh, Pennsylvania, United States

VA Wilkes Barre Medical Center; 🇺🇸 Wilkes-Barre, Pennsylvania, United States

Carolina Blood and Cancer Care Associates; 🇺🇸 Rock Hill, South Carolina, United States

Carolina Blood and Cancer Care Associate; 🇺🇸 Lancaster, South Carolina, United States

Providence; 🇺🇸 Portland, Oregon, United States

VA Miami Health Care System; 🇺🇸 Miami, Florida, United States

James A. Haley Veterans Hospital (VA Tampa); 🇺🇸 Tampa, Florida, United States

Southeast Louisiana Veterans Health Care System (SLVHCS) (VA New Orleans); 🇺🇸 New Orleans, Louisiana, United States

Boston VA Research Institute (VA Boston); 🇺🇸 Boston, Massachusetts, United States

VA Salt Lake City Health Care System (VASLCHCS); 🇺🇸 Salt Lake City, Utah, United States