Feasibility Evaluation of the Enzeavour Blood Test for Early Pancreatic Cancer Screening in Asymptomatic Adults Across Japan

What this Trial Is About

Pancreatic cancer is often diagnosed at an advanced stage, and there is no established effective population-based screening method. This study evaluates the Enzeavour Pancreatic Cancer assay, a blood test that measures three specific enzymes at a single-molecule level and combines four biomarkers into a composite Enzeavour Score. The trial is a nationwide, multicenter, prospective, single-arm feasibility study conducted in Japan, enrolling about 10,000 asymptomatic adults. Participants undergo the Enzeavour assay during routine health checkups or organized cancer screening visits. Those with an Enzeavour Score above 0.369 are referred for further diagnostic imaging, which may include MRCP, EUS, or contrast-enhanced CT based on clinical indications. This study uses a partial verification design with 12-month follow-up for specific subgroups to estimate pancreatic cancer detection rates and positive predictive value. Throughout the study, participants provide peripheral blood samples for the assay and may undergo diagnostic imaging if their test is positive. Researchers monitor pancreatic cancer detection within 12 months after the blood draw as the primary outcome and measure the positive predictive value of the assay as a secondary outcome. The study duration extends up to the end of 2028, with safety and diagnostic results followed during this period.

Pancreatic Cancer Screening Using the Enzeavour Assay in Japan