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 : February 4, 2022
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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: | 5 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, 2028 |
Group/Cohort | Intervention/treatment |
---|---|
Patients who received the Galleri test |
Other: MCED
multi-cancer early detection (MCED) test |
Patient 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 |
- Cancer detection rate [ Time Frame: Up to 5 Years ]
- Performance of Galleri: sensitivity, specificity, positive predictive value [ Time Frame: Up to 5 Years ]
- Population cancer detection rate [ Time Frame: Up to 5 Years ]
- Cancer signal detected [ Time Frame: Up to 5 Years ]Predicted cancer signal origin accuracy of the Galleri test
- Stage at diagnosis [ Time Frame: Up to 5 Years ]Distribution of cancer stage in those who received a cancer diagnosis following a Galleri cancer signal detected test result
- Time from test administration to cancer diagnosis [ Time Frame: Up to 5 Years ]
- Healthcare resource utilization (HCRU) [ Time Frame: Up to 5 Years ]
To assess short-term (12 month) HCRU for participants, stratified by Galleri test result and subsequent cancer diagnosis.
To assess long-term impact (>12 months) on HCRU in longitudinal care associated with Galleri.
- Adherence to cancer screening guidelines [ Time Frame: Up to 5 Years ]
- To describe the repeated use of Galleri test in patients [ Time Frame: Up to 5 Years ]including testing frequency and interval in a real-world setting.
- Patient self-report of acceptance of multi-cancer early detection [ Time Frame: Up to 5 Years ]
- Patient self-report of satisfaction with Galleri [ Time Frame: Up to 5 Years ]
- Provider self-report of satisfaction with Galleri [ Time Frame: Up to 5 Years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Participants will be recruited from participating healthcare delivery systems that offer Galleri as part of routine care.
Participants outside of health delivery systems (e.g., employers, individuals seeking Galleri) may also be recruited.
Inclusion Criteria:
- At least 18 years old at the time of consent
- Eligible to receive the Galleri test as determined by a healthcare provider
- Informed Consent
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 | Recruiting |
Scottsdale, Arizona, United States, 85260 | |
Contact: Christine Lau, MD 480-306-5390 | |
Principal Investigator: Vershalee Shukla, MD | |
United States, California | |
Providence | Recruiting |
Burbank, California, United States, 91505 | |
Contact: Jess Fleser | |
Principal Investigator: Ora Gordon, MD | |
United States, Oregon | |
Providence | Recruiting |
Portland, Oregon, United States, 97213 | |
Contact: Jess Fleser | |
Principal Investigator: Ora Gordon, MD | |
United States, South Carolina | |
Carolina Blood and Cancer Care Associate | Recruiting |
Lancaster, South Carolina, United States, 29720 | |
Contact: Dhwani Mehta | |
Principal Investigator: Sashi Naidu, MD | |
Carolina Blood and Cancer Care Associates | Recruiting |
Rock Hill, South Carolina, United States, 29732 | |
Contact: Dhwani Mehta 803-329-7772 | |
Principal Investigator: Sashi Naidu, MD |
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: | February 4, 2022 |
Last Verified: | February 2022 |
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 |