Pancreatic Cancer Screening Using the Enzeavour Assay in Japan (ENZEAVOUR FS)

Cosomil, Inc.

Status: Enrolling

Conditions: Pancreatic Neoplasms; Pancreatic Cancer

Treatments: Diagnostic Test: Enzeavour Pancreatic Cancer Assay

Study type: Interventional

Funder types: Industry

Identifiers

NCT07605819

JPNP23019 (Other Grant/Funding Number)

A250007-T (Other Identifier)

UMIN000059647 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10,000 participants in 1 patient group

Enzeavour Screening Pathway

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Enzeavour Pancreatic Cancer Assay