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REFLECTION: A Clinical Practice Learning Program for Galleri

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
Sponsor:
Information provided by (Responsible Party):
GRAIL, LLC

Study Description
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Brief Summary:
REFLECTION is a prospective cohort study that will enroll approximately 35,000 patients who have opted to be screened with Galleri, a blood-based, multi-cancer early detection (MCED) test as part of their routine medical care. The purpose of the study is to understand the performance of the test in clinical settings and the impact on patients and healthcare providers.

Condition or disease Intervention/treatment
Early Detection of Cancer Cancer Other: MCED Other: SOC

Study Design
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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
Groups and Cohorts
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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
 Other: SOC
standard of care cancer screening


Outcome Measures
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Primary Outcome Measures :
  1. Cancer detection rate [ Time Frame: Up to 5 Years ]
  2. Performance of Galleri: sensitivity, specificity, positive predictive value [ Time Frame: Up to 5 Years ]
  3. Population cancer detection rate [ Time Frame: Up to 5 Years ]
  4. Cancer signal detected [ Time Frame: Up to 5 Years ]
    Predicted cancer signal origin accuracy of the Galleri test

  5. 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


Secondary Outcome Measures :
  1. Time from test administration to cancer diagnosis [ Time Frame: Up to 5 Years ]
  2. 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.


  3. Adherence to cancer screening guidelines [ Time Frame: Up to 5 Years ]
  4. 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.


Other Outcome Measures:
  1. Patient self-report of acceptance of multi-cancer early detection [ Time Frame: Up to 5 Years ]
  2. Patient self-report of satisfaction with Galleri [ Time Frame: Up to 5 Years ]
  3. Provider self-report of satisfaction with Galleri [ Time Frame: Up to 5 Years ]

Eligibility Criteria
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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
Study Population

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.

Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: GRAIL Customer Service 833-694-2553 customerservice@grail.com

Locations
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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         
Sponsors and Collaborators
GRAIL, LLC
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GRAIL, LLC:
multi-cancer early detection
cancer screening
circulating cell-free tumor DNA