The Galleri® Community Research Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Data Collection. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- 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.]
Secondary outcome measures (2)
- 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.]
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- GRAIL — Menlo Park
Identifiers
NCT: NCT06603259 · GRAIL-MA-003