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Pancreatic Cancer Screening Using the Enzeavour Assay in Japan

NCT07605819 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2026-05-26

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Cosomil, Inc.

    lead INDUSTRY

Principal Investigators

  • Keiji Hanada, MD, Ph.D. · JA Onomichi General Hospital

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-04
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07605819 on ClinicalTrials.gov