Pancreatic Cancer Screening Using Single-Molecule Enzyme Activity-Based Liquid Biopsy, Enzeavour: A Single-Arm Interventional Feasibility Study Protocol in Japan
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Japan
JA Onomichi General Hospital
RECRUITING
Onomichi
Contact Information
Primary
Yu Kagami, Ph.D.
f-study@cosomil.com
+81-3-6823-2260
Time Frame
Start Date: 2026-02-04
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 10000
Treatments
Experimental: Enzeavour Screening Pathway
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.
Related Therapeutic Areas
Sponsors
Leads: Cosomil, Inc.