The Galleri® Community Research Program

GRAIL, the company that developed the Galleri test and is sponsoring this study, would like to learn more from individuals who have received the Galleri multi-cancer early detection test.

The purpose of this study is to understand how health information can be accurately collected from the medical records of individuals who have received the Galleri test in a real world setting. The collected information may include relevant medical and cancer history, diagnostic test results, including the Galleri test result. This will help GRAIL build a future larger study for individuals who have taken the Galleri test. This future study is important for understanding patient journeys after a Galleri test (including any diagnostic testing done and any diagnoses made), for improving the Galleri test, and to contribute to other research on cancer screening.

Study Overview

• Status: Enrolling by invitation
• Conditions: Data Collection

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

Study Locations

• United States
  • California
    • Menlo Park, California, United States, 94025
      • GRAIL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

up to 250 participants who have received test results following the Galleri test in the real world setting.

Description

Inclusion Criteria:

• Have received the Galleri test prescribed by a provider per clinical care
• Capable of giving signed and legally effective informed consent. Consent provided by a legally authorized representative is not permitted in this protocol.
• Have signed HIPAA authorization(s)* form for their medical records to be released and used for this study.

Exclusion Criteria:

• Patients are excluded from the study if the patient is a GRAIL employee or contractor.
• Patients who have received the Galleri test in a GRAIL-sponsored research setting (i.e., clinical trial) are excluded.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of data retrieved from participants who have received the Galleri test	Data quality is measured by data completeness and accuracy of key cancer outcome data elements retrieved from medical records for confirmed cancer cases of participants who received the Galleri test.	From enrollment to the the end of study (12 month study participation period), data will be retrieved and assessed for this measure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data retrieval methods will be described.	Summary of data retrieval methods, abstraction methods (e.g., manual, NLP assisted, LLM) that are used to abstract each key cancer outcome data element will be described. Additionally, the availability of each key cancer outcome data element depending on the time of abstraction following a Galleri test result will also be described.	From enrollment to the the end of study (12 month study participation period), data will be retrieved and assessed for this measure.
Describe the process of recruiting and consenting patients, and the retrieval of records in a narrative summary.	The process of recruiting and consenting patients, and the retrieval of records will be described in a narrative summary.	From enrollment to the the end of study (12 month study participation period), data will be retrieved and assessed for this measure.

Collaborators and Investigators

• Sponsor: GRAIL, Inc.
• Investigators: Principal Investigator: Mai Tran, MPA, GRAIL, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: observational; data collection; Multi-cancer early detection; Galleri test
• Other Study ID Numbers: GRAIL-MA-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No