Pancreatic Cancer Screening Using the Enzeavour Assay in Japan
ENZEAVOUR FS
3 other identifiers
interventional
10,000
1 country
48
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pancreatic-cancer
Started Feb 2026
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 4, 2026
CompletedFirst Submitted
Initial submission to the registry
May 11, 2026
CompletedFirst Posted
Study publicly available on registry
May 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
June 26, 2026
June 1, 2026
1.9 years
May 11, 2026
June 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Within 12 months after the index blood draw
Secondary Outcomes (1)
Positive Predictive Value of the Enzeavour Assay
Within 12 months after the index blood draw
Other Outcomes (4)
Detection Rates of Other Pancreatic Diseases and High-Risk Radiological Findings
Within 12 months after the index blood draw
Comparison With Conventional Tumor Markers
Baseline through 12 months
Imaging Correlates of Assay Results
Baseline through 12 months
- +1 more other outcomes
Study Arms (1)
Enzeavour Screening Pathway
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cosomil, Inc.lead
Study Sites (48)
Aichi Medical University Hospital
Nagakute, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
JA Onomichi General Hospital
Onomichi, Hiroshima, Japan
Obihiro Kosei Hospital
Obihiro, Hokkaido, Japan
Keijinkai Maruyama Clinic
Sapporo, Hokkaido, Japan
Teine Keijinkai Hospital
Sapporo, Hokkaido, Japan
Hotel Okura Kobe Clinic
Kobe, Hyōgo, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Ibaraki Medical Center
Mito, Ibaraki, Japan
Mito Kyodo General Hospital
Mito, Ibaraki, Japan
Kagawa University Hospital
Kita-gun Miki-cho, Kagawa-ken, Japan
JA Health Management Center Atsugi
Atsugi, Kanagawa, Japan
Isehara Kyodo Hospital
Isehara, Kanagawa, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, Japan
JA Health Management Center Sagamihara
Sagamihara, Kanagawa, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Clinic Green House
Kochi, Kochi, Japan
Japanese RedCross Society Kochi Red Cross Hospital
Kochi, Kochi, Japan
Kochi Kenshin Clinic
Kochi, Kochi, Japan
Kyoto Industrial Health Association
Kyoto, Kyoto, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
Matsusaka Medical Association
Matsusaka, Mie-ken, Japan
Mie Healthcare center
Tsu, Mie-ken, Japan
Mie University Hospital
Tsu, Mie-ken, Japan
Oita University Hospital
Yufu, Oita Prefecture, Japan
Nakagami General Chibana Clinic
Okinawa, Okinawa, Japan
Nakagami Hospital
Okinawa, Okinawa, Japan
Okinawa Health Promotion Foundation
Shimajiri-gun Haebaru-cho, Okinawa, Japan
NEO Healthcare GI Endoscopy Clinic Honmachi
Osaka, Osaka, Japan
Tane Clinic
Osaka, Osaka, Japan
Tane General Hospital
Osaka, Osaka, Japan
Jichi Medical University Saitama Medical Center
Saitama, Saitama, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, Japan
Seirei Preventive Health Care Center
Hamamatsu, Shizuoka, Japan
Medical Check Studio Tokyo Ginza Clinic
Chuo-ku, Tokyo, Japan
C'est la vie Shinbashi Clinic
Itabashi-ku, Tokyo, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan
Koganei Tsurukame Clinic
Koganei, Tokyo, Japan
The Jikei University Hospital
Minato-ku, Tokyo, Japan
Miraza Shinjuku Tsurukame Clinic
Shinjuku-ku, Tokyo, Japan
Shinjuku Tsurukame Clinic
Shinjuku-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan
Public Interest Incorporated Foundation Yamagata Health Promotion Organization
Yamagata, Yamagata, Japan
Yamagata University Hospital
Yamagata, Yamagata, Japan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keiji Hanada, MD, Ph.D.
JA Onomichi General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2026
First Posted
May 26, 2026
Study Start
February 4, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
June 26, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be made publicly available.