REFLECTION: A Clinical Practice Learning Program for Galleri®

N/AActive Not RecruitingNCT05205967

GRAIL, Inc.14,633 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

14,633

Conditions

Early Detection of Cancer Cancer

Interventions

MCEDOTHER

Multi-cancer early detection (MCED) test

SOCOTHER

Standard of care cancer screening

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (16)

Vincere Cancer Center

Scottsdale, Arizona, United States

Providence

Burbank, California, United States

Outcomes

Primary Outcomes

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

Time frame: Up to 12 Months

Secondary Outcomes

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

Time frame: Up to 12 Months

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

Time frame: Up to 12 Months

Data from ClinicalTrials.gov

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