Pancreatic Cancer Screen Test in Japan Using the Enzeavour Blood Assay

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a nationwide, multicenter, prospective, single-arm feasibility study in Japan. It evaluates the Enzeavour Pancreatic Cancer assay as part of routine health checkups and cancer screening. Adults without symptoms will be screened, and those with an Enzeavour Score above 0.369 will undergo further diagnostic work-up as clinically indicated. The study will follow participants for 12 months to estimate how often pancreatic cancer is detected and how often a positive test correctly predicts cancer. Real-world data from this design will inform planning for future trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• Aichi Medical University Hospital
  Nagakute, Aichi-ken, Japan Recruiting
• Chunichi Hospital
  Nagoya, Aichi-ken, Japan Recruiting
• Nagoya University Hospital
  Nagoya, Aichi-ken, Japan Recruiting
• Chiba University Hospital
  Chiba, Chiba, Japan Recruiting
• Fukuoka University Hospital
  Fukuoka, Fukuoka, Japan Recruiting
• Wellness Tenjin
  Fukuoka, Fukuoka, Japan Recruiting

+19 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Keiji Hanada, MD, Ph.D. — JA Onomichi General Hospital
• Study coordinator: Yu Kagami, Ph.D.
• Email: f-study@cosomil.com
• Phone: +81-3-6823-2260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.