View study details on clinicaltrials.gov.
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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 20,000 participants as defined by eligibility criteria over an anticipated enrollment period of approximately 18 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.
Nitin Rohatgi, MD, Kristie A. Bobolis, M.D., Alex J. Garica-Young, MD, Deepti Behl, MD, Sivakumar Reddy, M.D.