Pancreatic Cancer Screening Using the Enzeavour Assay in Japan
Recruiting · NCT07605819 · Interventional (participants receive a specific treatment) · Lead sponsor: Cosomil, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Enzeavour Pancreatic Cancer Assay
What this trial is about
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.
Who can take part
Age range
20 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
48 locations listed.
- Aichi Medical University Hospital - Nagakute, Aichi-ken, Japan
- Nagoya University Hospital - Nagoya, Aichi-ken, Japan
- Hiroshima University Hospital - Hiroshima, Hiroshima, Japan
- JA Onomichi General Hospital - Onomichi, Hiroshima, Japan
- Obihiro Kosei Hospital - Obihiro, Hokkaido, Japan
- Keijinkai Maruyama Clinic - Sapporo, Hokkaido, Japan
- Teine Keijinkai Hospital - Sapporo, Hokkaido, Japan
- Hotel Okura Kobe Clinic - Kobe, Hyōgo, Japan
- Kobe University Hospital - Kobe, Hyōgo, Japan
- Ibaraki Medical Center - Mito, Ibaraki, Japan
- Mito Kyodo General Hospital - Mito, Ibaraki, Japan
- Kagawa University Hospital - Kita-gun Miki-cho, Kagawa-ken, Japan
- JA Health Management Center Atsugi - Atsugi, Kanagawa, Japan
- Isehara Kyodo Hospital - Isehara, Kanagawa, Japan
- St. Marianna University School of Medicine Hospital - Kawasaki, Kanagawa, Japan
- JA Health Management Center Sagamihara - Sagamihara, Kanagawa, Japan
- Kitasato University Hospital - Sagamihara, Kanagawa, Japan
- Yokohama City University Medical Center - Yokohama, Kanagawa, Japan
- Clinic Green House - Kochi, Kochi, Japan
- Japanese RedCross Society Kochi Red Cross Hospital - Kochi, Kochi, Japan
- Kochi Kenshin Clinic - Kochi, Kochi, Japan
- Kyoto Industrial Health Association - Kyoto, Kyoto, Japan
- Kyoto University Hospital - Kyoto, Kyoto, Japan
- Matsusaka Medical Association - Matsusaka, Mie-ken, Japan
- Mie Healthcare center - Tsu, Mie-ken, Japan
- Mie University Hospital - Tsu, Mie-ken, Japan
- Oita University Hospital - Yufu, Oita Prefecture, Japan
- Nakagami General Chibana Clinic - Okinawa, Okinawa, Japan
- Nakagami Hospital - Okinawa, Okinawa, Japan
- Okinawa Health Promotion Foundation - Shimajiri-gun Haebaru-cho, Okinawa, Japan
- NEO Healthcare GI Endoscopy Clinic Honmachi - Osaka, Osaka, Japan
- Tane Clinic - Osaka, Osaka, Japan
- Tane General Hospital - Osaka, Osaka, Japan
- Jichi Medical University Saitama Medical Center - Saitama, Saitama, Japan
- Shiga University of Medical Science Hospital - Ōtsu, Shiga, Japan
- Seirei Hamamatsu General Hospital - Hamamatsu, Shizuoka, Japan
- Seirei Preventive Health Care Center - Hamamatsu, Shizuoka, Japan
- Medical Check Studio Tokyo Ginza Clinic - Chuo-ku, Tokyo, Japan
- C'est la vie Shinbashi Clinic - Itabashi-ku, Tokyo, Japan
- Nihon University Itabashi Hospital - Itabashi-ku, Tokyo, Japan
- Koganei Tsurukame Clinic - Koganei, Tokyo, Japan
- The Jikei University Hospital - Minato-ku, Tokyo, Japan
- Miraza Shinjuku Tsurukame Clinic - Shinjuku-ku, Tokyo, Japan
- Shinjuku Tsurukame Clinic - Shinjuku-ku, Tokyo, Japan
- Tokyo Women's Medical University Hospital - Shinjuku-ku, Tokyo, Japan
- Wakayama Medical University Hospital - Wakayama, Wakayama, Japan
- Public Interest Incorporated Foundation Yamagata Health Promotion Organization - Yamagata, Yamagata, Japan
- Yamagata University Hospital - Yamagata, Yamagata, Japan