REFLECTION: A Clinical Practice Learning Program for Galleri®

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05205967
• Other study ID #: GRAIL-MA-001
• Status: Recruiting
• Start date: August 23, 2021
• Est. completion date: August 23, 2026

Study information

• Verified date: April 2024
• Source: GRAIL, LLC
• Contact: GRAIL Customer Service
• Phone: 833-694-2553
• Email: customerservice[@]grail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17000
• Est. completion date: August 23, 2026
• Est. primary completion date: June 23, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Early Detection of Cancer

Intervention

Other:
• MCED
Multi-cancer early detection (MCED) test
• SOC
Standard of care cancer screening

Locations

Country	Name	City	State
United States	Boston VA Research Institute (VA Boston)	Boston	Massachusetts
United States	Providence	Burbank	California
United States	Providence, St. Jude	Fullerton	California
United States	Carolina Blood and Cancer Care Associate	Lancaster	South Carolina
United States	VA Miami Health Care System	Miami	Florida
United States	Providence, Mission	Mission Viejo	California
United States	WVU University Town Centre Family Medicine	Morgantown	West Virginia
United States	Southeast Louisiana Veterans Health Care System (SLVHCS) (VA New Orleans)	New Orleans	Louisiana
United States	Providence, Orange County	Orange	California
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania
United States	Providence	Portland	Oregon
United States	Carolina Blood and Cancer Care Associates	Rock Hill	South Carolina
United States	St. Helena Hospital (Adventist Health)	Saint Helena	California
United States	VA Salt Lake City Health Care System (VASLCHCS)	Salt Lake City	Utah
United States	Vincere Cancer Center	Scottsdale	Arizona
United States	James A. Haley Veterans Hospital (VA Tampa)	Tampa	Florida
United States	VA Wilkes Barre Medical Center	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
GRAIL, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	HCRU: To assess healthcare resource utilization (HCRU) associated with cancer diagnostic workups for participants with signal detected Galleri® test results.		Up to 12 Months