REFLECTION: A Clinical Practice Learning Program for Galleri®
- Conditions
- CancerEarly Detection of Cancer
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 17000
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.
- There are no exclusions
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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)
Vincere Cancer Center
🇺🇸Scottsdale, Arizona, United States
Providence
🇺🇸Portland, Oregon, United States
Providence, St. Jude
🇺🇸Fullerton, California, United States
Providence, Mission
🇺🇸Mission Viejo, California, United States
Providence, Orange County
🇺🇸Orange, California, United States
St. Helena Hospital (Adventist Health)
🇺🇸Saint Helena, California, 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
Scroll for more (6 remaining)Vincere Cancer Center🇺🇸Scottsdale, Arizona, United States