RecruitingNot ApplicableNCT07605819

Pancreatic Cancer Screening Using the Enzeavour Assay in Japan

Pancreatic Cancer Screening Using Single-Molecule Enzyme Activity-Based Liquid Biopsy, Enzeavour: A Single-Arm Interventional Feasibility Study Protocol in Japan

Sponsor

Cosomil, Inc.

Enrollment

10,000 participants

Start Date

Feb 4, 2026

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Pancreatic Neoplasms

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

Min Age: 20 Years

Inclusion Criteria2

Asymptomatic adults attending participating facilities for routine health checkups, organized cancer screening, or both
Able to understand the study procedures and provide written informed consent before enrollment

Exclusion Criteria3

Documented clinical history of pancreatic cancer
Considered unable or unwilling to undergo any required diagnostic imaging modality (MRCP, EUS, or contrast-enhanced CT) after a positive index test result
Any medical, psychological, or social condition that, in the opinion of the principal investigator at each participating site, makes participation inappropriate or compromises study integrity

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Interventions

DIAGNOSTIC_TESTEnzeavour 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.