This is a prospective, multi-center interventional study of the GRAIL multi-cancer early detection (MCED) test with return of test results for participants enrolled through healthcare systems in North America. The purpose of this study is to evaluate the safety and performance of the GRAIL MCED test in a population of individuals who are eligible for guideline-recommended cancer screening. In cases with a "cancer signal detected" test result, participants will undergo diagnostic procedures based on the test returned cancer signal origin(s) to determine if they have cancer. The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. Participant-reported outcomes will be collected at several time points to assess participants' perceptions about the multi-cancer early detection test. The study will enroll approximately 35,000 and no more than 38,500 participants as defined by eligibility criteria over an anticipated enrollment period of approximately 36 months at up to 40 clinical institutions within North America. Participants will be actively followed for approximately 3 years from the date of their enrollment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
35,883
Blood collection and multi-cancer early detection testing with return of results.
Sutter Health
Auburn, California, United States
Sutter Health
Davis, California, United States
Sutter Health
Elk Grove, California, United States
Sutter Health
Fairfield, California, United States
HOAG Irvine
Irvine, California, United States
HOAG Vivante Newport Mesa
Safety: Number and type of invasive procedures performed in participants with a cancer signal detected by the multi-cancer early detection (MCED) test and no cancer diagnosis at the time of diagnostic resolution (i.e., false positive test result).
Time frame: Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by positive predictive value (PPV).
Time frame: Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by negative predictive value (NPV).
Time frame: Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by sensitivity.
Time frame: Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by specificity.
Time frame: Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by cancer signal origin (CSO) accuracy.
Time frame: Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by observed cancer detection rate (CDR).
Time frame: Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by number needed to screen to detect an invasive cancer (NNS).
Time frame: Up to 3 Years
Participant-reported anxiety resulting from use of the multi-cancer early detection (MCED) test assessed via questionnaire at various time points during the study.
Time frame: Up to 3 Years
Participant-reported intention to follow and use guideline recommended cancer screening procedures after use of the multi-cancer early detection (MCED) test assessed via questionnaire at various time points during the study.
Time frame: Up to 3 Years
Cancer detection rate of confirmatory PET-CT in participants for whom cancer signal origin directed workups do not result in diagnosis of cancer.
Time frame: Up to 3 Years
Number and type of diagnostic evaluations (imaging procedures, invasive procedures, laboratory test) by predicted cancer signal origin and outcome of diagnostic resolution.
Time frame: Up to 3 Years
Per-participant radiation exposure during diagnostic evaluation for test positive participants.
Time frame: Up to 3 Years
Accuracy of initial multi-cancer early detection (MCED) test result and cancer signal origin prediction, among the subset of participants with a research blood draw.
Time frame: Up to 3 Years
Participants-reported perceptions about the multi-cancer early detection (MCED) test including satisfaction with the MCED tests and attitudes towards subsequent MCED testing assessed via questionnaire at various time points during the study.
Time frame: Up to 3 Years
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Irvine, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Sutter Health
Modesto, California, United States
HOAG Newport Beach
Newport Beach, California, United States
Palo Alto Medical Foundation
Palo Alto, California, United States
...and 46 more locations