Early Detection of CancerNCT05205967
REFLECTION: A Clinical Practice Learning Program for Galleri®
An observational study of Early Detection of Cancer and Cancer, run by GRAIL, Inc. at 16 sites in United States.
Trial summary
REFLECTION is a multi-center, prospective, non-interventional, cohort study that will enroll approximately 14,000 individuals who have opted to be screened with Galleri®, a blood-based, multi-cancer early detection (MCED) test in routine clinical settings. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Detection of Cancer, Cancer
- What is being tested?
- MCED and SOC
- How many people
- 14,633 participants
- Where
- 16 sitesUnited States
- Study dates
- 23 Aug 2021to 30 Oct 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll approximately 14,000 participants who meet the defined eligibility criteria.
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Participant has the ability to understand and the willingness to sign a written informed consent form (ICF);
- Participant is at least 22 years old at the time of consent;
- A provider or their designee has ordered the Galleri® test; and
- Participant has the ability to comprehend the participant questionnaires.
Who cannot join
- There are no exclusions
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Boston VA Research Institute (VA Boston)
Boston, Massachusetts, 02111-1750
Providence
Burbank, California, 91505
Providence, St. Jude
Fullerton, California, 92835
Carolina Blood and Cancer Care Associate
Lancaster, South Carolina, 29720
VA Miami Health Care System
Miami, Florida, 33125
Providence, Mission
Mission Viejo, California, 92691
WVU University Town Centre Family Medicine
Morgantown, West Virginia, 26501
Southeast Louisiana Veterans Health Care System (SLVHCS) (VA New Orleans)
New Orleans, Louisiana, 70119
Providence, Orange County
Orange, California, 92868
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
Providence
Portland, Oregon, 97213
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, 29732
VA Salt Lake City Health Care System (VASLCHCS)
Salt Lake City, Utah, 84148
Vincere Cancer Center
Scottsdale, Arizona, 85260
James A. Haley Veterans Hospital (VA Tampa)
Tampa, Florida, 33612
VA Wilkes Barre Medical Center
Wilkes-Barre, Pennsylvania, 18711
About this study
Official title: REFLECTION: Real World Evidence for Learnings in Early Cancer Detection, a Clinical Practice Learning Program for Galleri®
REFLECTION is a multi-center, prospective, non-interventional, cohort study that will enroll approximately 14,000 individuals who have opted to be screened with Galleri®, a blood-based, multi-cancer early detection (MCED) test in routine clinical settings. The purpose of the study is to understand the real-world experience of Galleri® in clinical settings.
- Conditions
- Early Detection of Cancer, Cancer
- Being tested
- MCED, SOC
- Keywords
- Multi-cancer early detection, Cancer screening, Circulating cell-free tumor DNA
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCEDOther
Multi-cancer early detection (MCED) test
SOCOther
Standard of care cancer screening
| Study group | Role | What they receive |
|---|---|---|
| Patients who received the Galleri® test. | Not described Receives: Other: MCED; Other: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe signal detection and cancer detection within and across sites among participants who opt to receive Galleri® in a real world setting.
Measured: Up to 12 Months
Secondary outcomes (2)
Galleri®: To assess the feasibility and acceptability of Galleri® from the perspective of participants and patient-reported outcomes (PROs) in a real-world setting.
Measured: Up to 12 Months
HCRU: To assess healthcare resource utilization (HCRU) associated with cancer diagnostic workups for participants with signal detected Galleri® test results.
Measured: Up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start23 Aug 2021
- Primary completion30 Sep 2025
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Detection of CancerStudies 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
- Prospective
- Enrolment
- 14,633 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- GRAIL, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205967
- Sponsor's protocol ID
- GRAIL-MA-001
- Status last verified
- Nov 2025
- First submitted
- 14 Sep 2021
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kortlever TL, Ferlizza E, Lauriola M, Borrelli F, Porro A, Spaander MCW, Bossuyt PM, Ricciardiello L, Dekker E. Diagnostic Accuracy of an Add-On, Blood-Based Screening Test for Colorectal Cancer in Two Established Screening Programmes. Aliment Pharmacol Ther. 2025 Jun;61(12):1935-1943. doi: 10.1111/apt.70141. Epub 2025 Apr 10.
PubMed 40207404
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REFLECTION: Real World Evidence for Learnings in Early Cancer Detection, a Clinical Practice Learning Program for Galleri®
- ClinicalTrials.gov ID
- NCT05205967
- Acronym / sponsor ID
- GRAIL-MA-001
- Conditions
- Early Detection of Cancer, Cancer
- Keywords
- Multi-cancer early detection, Cancer screening, Circulating cell-free tumor DNA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 14,633 participants (actual)
- Lead sponsor
- GRAIL, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 25 Jan 2022 (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.
REFLECTION is a multi-center, prospective, non-interventional, cohort study that will enroll approximately 14,000 individuals who have opted to be screened with Galleri®, a blood-based, multi-cancer early detection (MCED) test in routine clinical settings. The purpose of the study is to understand the real-world experience of Galleri® in clinical settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received the Galleri® test. | – | Other: MCED, Other: SOC |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll approximately 14,000 participants who meet the defined eligibility criteria.
Key inclusion criteria (5 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Participant has the ability to understand and the willingness to sign a written informed consent form (ICF);
- Participant is at least 22 years old at the time of consent;
- A provider or their designee has ordered the Galleri® test; and
- Participant has the ability to comprehend the participant questionnaires.
Key exclusion criteria (1 listed)
- There are no exclusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCEDMulti-cancer early detection (MCED) test | Other | Patients who received the Galleri® test. |
| SOCStandard of care cancer screening | Other | Patients who received the Galleri® test. |
Primary outcome
To describe signal detection and cancer detection within and across sites among participants who opt to receive Galleri® in a real world setting.
Time frame: Up to 12 Months
2 secondary outcomes
Galleri®: To assess the feasibility and acceptability of Galleri® from the perspective of participants and patient-reported outcomes (PROs) in a real-world setting.
Time frame: Up to 12 Months
HCRU: To assess healthcare resource utilization (HCRU) associated with cancer diagnostic workups for participants with signal detected Galleri® test results.
Time frame: Up to 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Derived from this study: PubMed 40207404Kortlever TL, Ferlizza E, Lauriola M, Borrelli F, Porro A, Spaander MCW, Bossuyt PM, Ricciardiello L, Dekker E. Diagnostic Accuracy of an Add-On, Blood-Based Screening Test for Colorectal Cancer in Two Established Screening Programmes. Aliment Pharmacol Ther. 2025 Jun;61(12):1935-1943. doi: 10.1111/apt.70141. Epub 2025 Apr 10.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Detection of Cancer and Cancer, run by GRAIL, Inc. at 16 sites 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
To describe signal detection and cancer detection within and across sites among participants who opt to receive Galleri® in a real world setting. (time frame: Up to 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05205967, which also lists 1 linked publication.
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 26 Nov 2025.