The Galleri® Community Research Program

NCT ID: NCT06603259

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-19

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Data Collection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GRAIL, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mai Tran, MPA

Role: PRINCIPAL_INVESTIGATOR

GRAIL, Inc.

Locations

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GRAIL

Menlo Park, California, United States

Site Status

Countries

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United States

Other Identifiers

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GRAIL-MA-003

Identifier Type: -

Identifier Source: org_study_id

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