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REFLECTION: A Clinical Practice Learning Program for Galleri

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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

Tracking Information
First Submitted Date September 14, 2021
First Posted Date January 25, 2022
Last Update Posted Date February 4, 2022
Actual Study Start Date August 23, 2021
Estimated Primary Completion Date August 23, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 12, 2022)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 12, 2022)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 12, 2022)
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title REFLECTION: A Clinical Practice Learning Program for Galleri
Official Title REFLECTION: Real World Evidence for Learnings in Early Cancer Detection, a Clinical Practice Learning Program for Galleri™
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
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.
Condition
  • Early Detection of Cancer
  • Cancer
Intervention
  • Other: MCED
    multi-cancer early detection (MCED) test
  • Other: SOC
    standard of care cancer screening
Study Groups/Cohorts
  • Patients who received the Galleri test
    Intervention: Other: MCED
  • Patient who were eligible to receive the Galleri test but did not
    External contemporaneous control cohort
    Intervention: Other: SOC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 12, 2022)		 35000
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 23, 2028
Estimated Primary Completion Date August 23, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: GRAIL Customer Service 833-694-2553 customerservice@grail.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05205967
Other Study ID Numbers GRAIL-MA-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party GRAIL, LLC
Original Responsible Party Same as current
Current Study Sponsor GRAIL, LLC
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account GRAIL, LLC
Verification Date February 2022