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NCT Number: NCT05205967

REFLECTION: A Clinical Practice Learning Program for Galleri®

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Early Detection of Cancer Cancer Neoplasms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vincere Cancer Center, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCED

Other

Multi-cancer early detection (MCED) test

SOC

Other

Standard of care cancer screening

Primary outcomes

  1. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

GRAIL, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jan 25, 2022
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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