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 all (48) locations...
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 Health Management Center Atsugi
RECRUITING
Atsugi
Medical Check Studio Tokyo Ginza Clinic
RECRUITING
Chuo-ku
Seirei Hamamatsu General Hospital
RECRUITING
Hamamatsu
Seirei Preventive Health Care Center
RECRUITING
Hamamatsu
Hiroshima University Hospital
RECRUITING
Hiroshima
Isehara Kyodo Hospital
RECRUITING
Isehara
C'est la vie Shinbashi Clinic
RECRUITING
Itabashi-ku
Nihon University Itabashi Hospital
RECRUITING
Itabashi-ku
St. Marianna University School of Medicine Hospital
RECRUITING
Kawasaki
Kagawa University Hospital
RECRUITING
Kita-gun Miki-cho
Hotel Okura Kobe Clinic
RECRUITING
Kobe
Kobe University Hospital
RECRUITING
Kobe
Clinic Green House
RECRUITING
Kochi
Japanese RedCross Society Kochi Red Cross Hospital
RECRUITING
Kochi
Kochi Kenshin Clinic
RECRUITING
Kochi
Koganei Tsurukame Clinic
RECRUITING
Koganei
Kyoto Industrial Health Association
RECRUITING
Kyoto
Kyoto University Hospital
RECRUITING
Kyoto
Matsusaka Medical Association
RECRUITING
Matsusaka
The Jikei University Hospital
RECRUITING
Minato-ku
Ibaraki Medical Center
RECRUITING
Mito
Mito Kyodo General Hospital
RECRUITING
Mito
Aichi Medical University Hospital
RECRUITING
Nagakute
Nagoya University Hospital
RECRUITING
Nagoya
Obihiro Kosei Hospital
RECRUITING
Obihiro
Nakagami General Chibana Clinic
RECRUITING
Okinawa
Nakagami Hospital
RECRUITING
Okinawa
JA Onomichi General Hospital
RECRUITING
Onomichi
NEO Healthcare GI Endoscopy Clinic Honmachi
RECRUITING
Osaka
Tane Clinic
RECRUITING
Osaka
Tane General Hospital
RECRUITING
Osaka
Shiga University of Medical Science Hospital
RECRUITING
Ōtsu
JA Health Management Center Sagamihara
RECRUITING
Sagamihara
Kitasato University Hospital
RECRUITING
Sagamihara
Jichi Medical University Saitama Medical Center
RECRUITING
Saitama
Keijinkai Maruyama Clinic
RECRUITING
Sapporo
Teine Keijinkai Hospital
RECRUITING
Sapporo
Okinawa Health Promotion Foundation
RECRUITING
Shimajiri-gun Haebaru-cho
Miraza Shinjuku Tsurukame Clinic
RECRUITING
Shinjuku-ku
Shinjuku Tsurukame Clinic
RECRUITING
Shinjuku-ku
Tokyo Women's Medical University Hospital
RECRUITING
Shinjuku-ku
Mie Healthcare center
RECRUITING
Tsu
Mie University Hospital
RECRUITING
Tsu
Wakayama Medical University Hospital
RECRUITING
Wakayama
Public Interest Incorporated Foundation Yamagata Health Promotion Organization
RECRUITING
Yamagata
Yamagata University Hospital
RECRUITING
Yamagata
Yokohama City University Medical Center
RECRUITING
Yokohama
Oita University Hospital
RECRUITING
Yufu
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.