Beaverton

Researchers are evaluating the Galleri4 multi-cancer early detection (MCED) test in a multi-center prospective cohort study involving the Medicare population aged 50 years and older. This study aims to understand the real-world clinical impact of the test, including its safety and how well it detects cancers early. The study seeks to enroll participants who represent the Medicare population, including those with Traditional Medicare or Medicare Advantage coverage. Participants in the study are divided into two groups: one group receives the Galleri test through blood collection and multi-cancer early detection testing with return of results, while the other group receives usual care without the Galleri test. The study excludes individuals who have previously had an MCED test, are undergoing clinical evaluation for suspected cancer, have certain recent or untreated cancer histories, are pregnant, or are currently inpatient at a participating site. The study is designed to monitor participants over time without specifying a maximum age limit. During the study, researchers will track the incidence rates of stage IV cancers over a period of up to 3 years. Participants will be monitored for safety and test performance outcomes. The study involves informed consent from participants who are capable of providing it directly, and it excludes those who cannot comply with study procedures or who are not registered patients at participating centers. This research aims to provide data on the effectiveness and safety of the Galleri test in a real-world Medicare population setting.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.