Data CollectionNCT06603259
The Galleri® Community Research Program
An observational study of Data Collection, run by GRAIL, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Data Collection
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: up to 250 participants who have received test results following the Galleri test in the real world setting.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
The process of recruiting and consenting patients, and the retrieval of records will be described in a narrative summary.
Measured: From enrollment to the the end of study (12 month study participation period), data will be retrieved and assessed for this measure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Aug 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Data CollectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- GRAIL, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mai Tran, MPA, Principal investigator, GRAIL, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603259
- Sponsor's protocol ID
- GRAIL-MA-003
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Galleri® Community Research Program
- ClinicalTrials.gov ID
- NCT06603259
- Acronym / sponsor ID
- GRAIL-MA-003
- Conditions
- Data Collection
- Keywords
- observational, Galleri test, Multi-cancer early detection, data collection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- GRAIL, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- up to 250 participants who have received test results following the Galleri test in the real world setting.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai Tran, MPA principal investigator
GRAIL, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Data Collection, run by GRAIL, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.