REFLECTION: A Clinical Practice Learning Program for Galleri®
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05205967 |
Recruitment Status :
Recruiting
First Posted : January 25, 2022
Last Update Posted : April 18, 2023
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Condition or disease | Intervention/treatment |
---|---|
Early Detection of Cancer Cancer | Other: MCED Other: SOC |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 35000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 3 Years |
Official Title: | REFLECTION: Real World Evidence for Learnings in Early Cancer Detection, a Clinical Practice Learning Program for Galleri® |
Actual Study Start Date : | August 23, 2021 |
Estimated Primary Completion Date : | August 23, 2024 |
Estimated Study Completion Date : | August 23, 2026 |
Group/Cohort | Intervention/treatment |
---|---|
Patients who received the Galleri® test |
Other: MCED
multi-cancer early detection (MCED) test |
Patients who were eligible to receive the Galleri® test but did not
External contemporaneous control cohort
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Other: SOC
standard of care cancer screening |
- Overall Cancer Detection Rate (CDR) for the study population. [ Time Frame: Up to 3 Years ]
- Additional performance metrics of Galleri include the following: [ Time Frame: Up to 3 Years ]● Predicted cancer signal origin accuracy.
- Time from Galleri test result to cancer status (this would include an evaluation of true positives [TPs] and false positives [FPs]). [ Time Frame: Up to 3 Years ]
- Short-term HCRU: To assess short-term healthcare resource utilization (HCRU) for participants, stratified by Galleri test result. [ Time Frame: Up to 3 Years ]Short-term HCRU (from the time of delivering Galleri test result to the time of a confirmed cancer status)stratified by Galleri test result, with particular consideration of high-cost items (e.g., MRI, PET scan) vs. invasive procedures (colonoscopy/endoscopy).
- Survey responses regarding intent to adhere to guidelines will be reported. The association between the intention of adherence and EHR evidence of adherence will be assessed. [ Time Frame: Up to 3 Years ]
- Long-term HCRU: To assess differences in long-term HCRU between the Galleri and control cancer patients. [ Time Frame: Up to 3 Years ]Differences in long-term HCRU (from the time of a cancer diagnosis to the end of study) between the Galleri and control arms among cancer patients.
- CDR, Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) stratified by subpopulations of clinical interest such as cancer survivors, cancer type, stage, age group, sex, and race/ethnicity. [ Time Frame: Up to 3 Years ]

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Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Prospective approval of clinical study protocol deviations to recruitment and enrollment criteria, also known as clinical study protocol waivers (protocol waivers) or clinical study protocol exemptions (protocol exemptions), is not permitted.
The study will enroll approximately 35,000 participants who meet the defined eligibility criteria below.
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
- At least 22 years old at the time of blood draw for the Galleri® test.
- Participant has received their first Galleri® test within 6 months prior to consent, or participant has received their first Galleri® test within 6 months after consent.
- Informed Consent - Capable of giving signed and legally effective informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
Exclusion Criteria:
- There are no exclusions

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05205967
Contact: GRAIL Customer Service | 833-694-2553 | customerservice@grail.com |
United States, Arizona | |
Vincere Cancer Center | Active, not recruiting |
Scottsdale, Arizona, United States, 85260 | |
United States, California | |
Providence | Recruiting |
Burbank, California, United States, 91505 | |
Contact: Jess Fleser | |
Principal Investigator: Gordon Ora, MD | |
Providence, St. Jude | Recruiting |
Fullerton, California, United States, 92835 | |
Contact: Jess Fleser | |
Principal Investigator: Gordon Ora, MD | |
Providence, Mission | Recruiting |
Mission Viejo, California, United States, 92691 | |
Contact: Jess Fleser | |
Principal Investigator: Gordon Ora, MD | |
Providence, Orange County | Recruiting |
Orange, California, United States, 92868 | |
Contact: Jess Fleser | |
Principal Investigator: Gordon Ora, MD | |
St. Helena Hospital (Adventist Health) | Withdrawn |
Saint Helena, California, United States, 94574 | |
United States, Oregon | |
Providence | Recruiting |
Portland, Oregon, United States, 97213 | |
Contact: Jess Fleser | |
Principal Investigator: Gordon Ora, MD | |
United States, Pennsylvania | |
VA Pittsburgh Healthcare System | Recruiting |
Pittsburgh, Pennsylvania, United States, 15240 | |
Contact: Karen Smith 412-360-2410 Karen.Smith50@va.gov | |
Principal Investigator: Charles Atwood | |
United States, South Carolina | |
Carolina Blood and Cancer Care Associate | Active, not recruiting |
Lancaster, South Carolina, United States, 29720 | |
Carolina Blood and Cancer Care Associates | Active, not recruiting |
Rock Hill, South Carolina, United States, 29732 |
Responsible Party: | GRAIL, LLC |
ClinicalTrials.gov Identifier: | NCT05205967 |
Other Study ID Numbers: |
GRAIL-MA-001 |
First Posted: | January 25, 2022 Key Record Dates |
Last Update Posted: | April 18, 2023 |
Last Verified: | April 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
multi-cancer early detection cancer screening circulating cell-free tumor DNA |