The Galleri® Community Research Program

NCT06603259 | Enrolling By Invitation

• 1 other identifier: GRAIL-MA-003
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Data Collection

Keywords

observational; Galleri test; Multi-cancer early detection; data collection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Data retrieval methods will 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.

  From enrollment to the the end of study (12 month study participation period), data will be retrieved and assessed for this measure.

Eligibility Criteria

• Gender Eligibility Details: Biologically male and female at birth
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GRAIL, Inc.: lead

Study Sites (1)

GRAIL

Menlo Park, California, 94025, United States

Location

Study Officials

• Mai Tran, MPA

  GRAIL, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: August 19, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)