Pancreatic Cancer Screening Using the Enzeavour Assay in Japan

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

Pancreatic cancer is often diagnosed at an advanced stage, and an effective population-based screening strategy has not been established. The Enzeavour Pancreatic Cancer assay is a blood-based test that quantifies the activity of three specific enzymes at a single-molecule level and integrates four biomarkers into a composite Enzeavour Score. This nationwide, multicenter, prospective, single-arm feasibility study evaluates the Enzeavour assay in routine health checkups and cancer screening in Japan. Approximately 10,000 asymptomatic adults will be enrolled. Participants with an Enzeavour Score greater than 0.369 will be referred for diagnostic work-up as clinically indicated. This study uses a partial verification design with 12-month follow-up for pre-specified subgroups and aims to generate real-world estimates of pancreatic cancer detection rate and positive predictive value for future trial planning.

Intervention public domain (ClinicalTrials.gov)

Diagnostic_Test: 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.

Arm public domain (ClinicalTrials.gov)

Enzeavour Screening Pathway (experimental): Participants undergo peripheral blood collection for the Enzeavour Pancreatic Cancer assay as part of a routine health checkup or organized cancer screening visit. Participants with a positive assay result, defined as an Enzeavour Score greater than 0.369, are referred for diagnostic work-up, including MRCP, EUS, or contrast-enhanced CT, as clinically indicated.

Primary outcome public domain (ClinicalTrials.gov)

Pancreatic Cancer Detection Rate. 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. Time frame: Within 12 months after the index blood draw.

Secondary outcome public domain (ClinicalTrials.gov)

Positive Predictive Value of the Enzeavour Assay. Time frame: Within 12 months after the index blood draw.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: * 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 Criteria: * 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

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 10000 participants (estimated).