The Galleri® Community Research Program

• Conditions: Data Collection

• Registration Number: NCT06603259
• Lead Sponsor: GRAIL, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-19
• Status Verified: 2024-09
• Study First Submitted: 2024-09-17
• Study First Submitted QC: 2024-09-17
• Last Update Submitted: 2024-09-17
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 250

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of data retrieved from participants who have 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.	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	The process of recruiting and consenting patients, and the retrieval of records will be described in a narrative summary.

Trial Locations

Locations (1)

GRAIL; 🇺🇸 Menlo Park, California, United States