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.

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Key information

Conditions

Data Collection

Sex eligibility

All sexes

Study type

Observational

Primary location

GRAIL

Menlo Park, California, 94025, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

Quality of data retrieved from participants who have received the Galleri test

Time frame: 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 outcomes

Data retrieval methods will be described.

Time frame: 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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

GRAIL, Inc.

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 19, 2024
Registry last updated: Sep 19, 2024

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.

Published trials that share one or more normalized conditions with this study.

Completed