Cancer, Early Detection of Cancer
Conditions
Keywords
Multi-cancer early detection, Cancer screening, Circulating cell-free tumor DNA
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.
Interventions
OTHERMCED
Multi-cancer early detection (MCED) test
OTHERSOC
Standard of care cancer screening
Sponsors
GRAIL, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed