Pancreatic Cancer Screening Using the Enzeavour Assay in Japan

Condition(s) studied

Investigational drug(s) / intervention(s)

Enzeavour Pancreatic Cancer Assay: A blood-based diagnostic assay that quantifies the activity of three specific enzymes at a single-molecule level. Four biomarkers derived from these measurements are integrated into a composite Enzeavour Score using a predefined discriminant function. Participants with a score above the pre-specified cut-off of 0.369 are considered test-positive and referred for diagnostic work-up.

Study summary

This nationwide, multicenter, prospective, single-arm interventional feasibility study evaluates the Enzeavour Pancreatic Cancer assay in routine health checkups and cancer screening in Japan. Approximately 10,000 asymptomatic adults will be enrolled. Participants with an Enzeavour Score above 0.369 will undergo diagnostic work-up as clinically indicated. The primary outcome is pancreatic cancer detection rate within 12 months after the index blood draw, and the secondary outcome is positive predictive value.

Eligibility

Primary outcome measure(s)

• Pancreatic Cancer Detection Rate — Within 12 months after the index blood draw
  The proportion of all enrolled participants diagnosed with pancreatic cancer within 12 months of the index blood draw. A confirmed case is defined as pancreatic cancer confirmed histopathologically or cytologically, or clinically diagnosed based on multidisciplinary team judgment.

Trial sites (48)

+ 8 more sites — see the full list on the official registry below.

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