Study of the GRAIL Galleri Blood Test for Early Detection of Multiple Cancers in People at Higher Risk

What this Trial Is About

Researchers are studying an investigational blood test called the GRAIL Galleri test, designed to detect many types of cancer early. This study focuses on people at slightly higher than average risk of developing certain cancers, including those with genetic cancer predisposition syndromes or a strong family history of cancer. The goal is to evaluate the benefits and possible harms of this multi-cancer early detection MCED test in a prospective, interventional setting lasting up to three years. Participants will undergo baseline questionnaires and a blood test using the Galleri MCED test. Depending on the test result, follow-up may vary those with a negative test will have recommended cancer screenings and a follow-up phone call one year later, while those with a positive test may have additional clinic visits, lab tests, biopsies, surgeries, or imaging scans such as ultrasound, CT, or MRI. If cancer is confirmed, participants will complete a post-diagnostic questionnaire. During the study, participants will complete questionnaires and blood tests at scheduled visits. Researchers will monitor cancer detection rates up to two years and track outcomes like cancer stage at diagnosis, positive predictive value at 12 and 24 months, time to diagnostic resolution, participant anxiety, quality of life, and costs related to follow-up testing. The study expects to enroll about 1,000 people and lasts up to three years, including follow-up assessments and safety monitoring.

Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Population: The INFORM Study