Pancreatic Cancer Screening Using the Enzeavour Assay in Japan

Recruiting now · Not applicable

Conditions studied: Pancreatic Cancer, Pancreatic Neoplasms

In brief

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.

Key facts

Study ID

NCT07605819

Run by

Cosomil, Inc.

People needed

10000

Starts

2026-02-04

Expected to finish

2028-12-31

Last updated by the study team

2026-06-26

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Aichi Medical University Hospital — Nagakute, Aichi-ken, Japan (enrolling)
• Nagoya University Hospital — Nagoya, Aichi-ken, Japan (enrolling)
• Hiroshima University Hospital — Hiroshima, Hiroshima, Japan (enrolling)
• JA Onomichi General Hospital — Onomichi, Hiroshima, Japan (enrolling)
• Obihiro Kosei Hospital — Obihiro, Hokkaido, Japan (enrolling)
• Keijinkai Maruyama Clinic — Sapporo, Hokkaido, Japan (enrolling)
• Teine Keijinkai Hospital — Sapporo, Hokkaido, Japan (enrolling)
• Hotel Okura Kobe Clinic — Kobe, Hyōgo, Japan (enrolling)
• Kobe University Hospital — Kobe, Hyōgo, Japan (enrolling)
• Ibaraki Medical Center — Mito, Ibaraki, Japan (enrolling)
• Mito Kyodo General Hospital — Mito, Ibaraki, Japan (enrolling)
• Kagawa University Hospital — Kita-gun Miki-cho, Kagawa-ken, Japan (enrolling)
• JA Health Management Center Atsugi — Atsugi, Kanagawa, Japan (enrolling)
• Isehara Kyodo Hospital — Isehara, Kanagawa, Japan (enrolling)
• St. Marianna University School of Medicine Hospital — Kawasaki, Kanagawa, Japan (enrolling)
• JA Health Management Center Sagamihara — Sagamihara, Kanagawa, Japan (enrolling)
• Kitasato University Hospital — Sagamihara, Kanagawa, Japan (enrolling)
• Yokohama City University Medical Center — Yokohama, Kanagawa, Japan (enrolling)
• Clinic Green House — Kochi, Kochi, Japan (enrolling)
• Japanese RedCross Society Kochi Red Cross Hospital — Kochi, Kochi, Japan (enrolling)
• Kochi Kenshin Clinic — Kochi, Kochi, Japan (enrolling)
• Kyoto Industrial Health Association — Kyoto, Kyoto, Japan (enrolling)
• Kyoto University Hospital — Kyoto, Kyoto, Japan (enrolling)
• Matsusaka Medical Association — Matsusaka, Mie-ken, Japan (enrolling)
• Mie Healthcare center — Tsu, Mie-ken, Japan (enrolling)

Full record on ClinicalTrials.gov

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