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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 : January 18, 2023
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.

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: 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
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
Patients 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. Overall Cancer Detection Rate (CDR) for the study population. [ Time Frame: Up to 3 Years ]
  2. Additional performance metrics of Galleri include the following: [ Time Frame: Up to 3 Years ]
    ● Predicted cancer signal origin accuracy.


Secondary Outcome Measures :
  1. 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 ]
  2. 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).

  3. 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 ]
  4. 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.

  5. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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.


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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
Study Population

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.

Criteria

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
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: 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         
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
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: January 18, 2023
Last Verified: January 2023
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