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Pancreatic Cancer Screening Using the Enzeavour Assay in Japan
Pancreatic Cancer Screening Using the Enzeavour Assay in Japan

NCT07605819

RecruitingNA

Sponsor: Cosomil, Inc.

Conditions: Pancreatic Cancer, Pancreatic Neoplasms

Interventions: Enzeavour Pancreatic Cancer Assay

Countries: Japan

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 overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (48)
  • Nagakute, Aichi-ken, Japan
  • Nagoya, Aichi-ken, Japan
  • Hiroshima, Hiroshima, Japan
  • Onomichi, Hiroshima, Japan
  • Obihiro, Hokkaido, Japan
  • Sapporo, Hokkaido, Japan
  • Sapporo, Hokkaido, Japan
  • Kobe, Hyōgo, Japan
  • Kobe, Hyōgo, Japan
  • Mito, Ibaraki, Japan
  • Mito, Ibaraki, Japan
  • Kita-gun Miki-cho, Kagawa-ken, Japan
  • Atsugi, Kanagawa, Japan
  • Isehara, Kanagawa, Japan
  • Kawasaki, Kanagawa, Japan
  • Sagamihara, Kanagawa, Japan
  • Sagamihara, Kanagawa, Japan
  • Yokohama, Kanagawa, Japan
  • Kochi, Kochi, Japan
  • Kochi, Kochi, Japan
  • Kochi, Kochi, Japan
  • Kyoto, Kyoto, Japan
  • Kyoto, Kyoto, Japan
  • Matsusaka, Mie-ken, Japan
  • Tsu, Mie-ken, Japan
  • Tsu, Mie-ken, Japan
  • Yufu, Oita Prefecture, Japan
  • Okinawa, Okinawa, Japan
  • Okinawa, Okinawa, Japan
  • Shimajiri-gun Haebaru-cho, Okinawa, Japan
  • + 18 more on CT.gov