Pancreatic Cancer Screening Using the Enzeavour Assay in Japan
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorCosomil, Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Enzeavour Pancreatic Cancer Assay
Treatment groups
10,000 Participants
are divided into 1 treatment groupLocations
48Aichi Medical University Hospital NagakuteAichi-ken, Japan
Nagoya University Hospital NagoyaAichi-ken, Japan
Hiroshima University Hospital HiroshimaHiroshima, Japan
JA Onomichi General Hospital OnomichiHiroshima, Japan
Sponsors and collaborators
Cosomil, Inc.
Lead sponsor
Source ClinicalTrials.gov