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Pancreatic Cancer Screening Using the Enzeavour Assay in Japan
Sponsor: Cosomil, Inc.
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.
Official title: Pancreatic Cancer Screening Using Single-Molecule Enzyme Activity-Based Liquid Biopsy, Enzeavour: A Single-Arm Interventional Feasibility Study Protocol in Japan
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10000
Start Date
2026-02-04
Completion Date
2028-12-31
Last Updated
2026-06-26
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (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