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| ID | Type | Description | Link |
|---|---|---|---|
| JPNP23019 | Other Grant/Funding Number | The New Energy and Industrial Technology Development Organization (NEDO) | |
| UMIN000059647 | Registry Identifier | University hospital Medical Information Network (UMIN) Center | |
| A250007-T | Other Identifier | Kobe University Hospital Interventional Research Ethics Committee |
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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.
Pancreatic cancer is often diagnosed at an advanced stage, and an effective population-based screening strategy has not been established. The Enzeavour Pancreatic Cancer assay is a blood-based test that quantifies the activity of three specific enzymes at a single-molecule level and integrates four biomarkers into a composite Enzeavour Score.
This nationwide, multicenter, prospective, single-arm feasibility study evaluates the Enzeavour assay in routine health checkups and cancer screening in Japan. Approximately 10,000 asymptomatic adults will be enrolled. Participants with an Enzeavour Score greater than 0.369 will be referred for diagnostic work-up as clinically indicated. This study uses a partial verification design with 12-month follow-up for pre-specified subgroups and aims to generate real-world estimates of pancreatic cancer detection rate and positive predictive value for future trial planning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzeavour Screening Pathway | Experimental | Participants undergo peripheral blood collection for the Enzeavour Pancreatic Cancer assay as part of a routine health checkup or organized cancer screening visit. Participants with a positive assay result, defined as an Enzeavour Score greater than 0.369, are referred for diagnostic work-up, including MRCP, EUS, or contrast-enhanced CT, as clinically indicated. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzeavour Pancreatic Cancer Assay | Diagnostic Test | A blood-based diagnostic assay that quantifies the activity of three specific enzymes at a single-molecule level. Four biomarkers derived from these measurements are integrated into a composite Enzeavour Score using a predefined discriminant function. Participants with a score above the pre-specified cut-off of 0.369 are considered test-positive and referred for diagnostic work-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Pancreatic Cancer Detection Rate | The proportion of all enrolled participants diagnosed with pancreatic cancer within 12 months of the index blood draw. A confirmed case is defined as pancreatic cancer confirmed histopathologically or cytologically, or clinically diagnosed based on multidisciplinary team judgment. | Within 12 months after the index blood draw |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Predictive Value of the Enzeavour Assay | The proportion of participants with a positive index test result, defined as an Enzeavour Score greater than 0.369, who are subsequently diagnosed with histopathologically confirmed pancreatic cancer within 12 months after the index blood draw. | Within 12 months after the index blood draw |
| Measure | Description | Time Frame |
|---|---|---|
| Detection Rates of Other Pancreatic Diseases and High-Risk Radiological Findings | Descriptive analysis of detection rates for various pancreatic diseases and high-risk radiological findings identified during diagnostic work-up and follow-up. | Within 12 months after the index blood draw |
| Comparison With Conventional Tumor Markers |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Kagami, Ph.D. | Contact | +81-3-6823-2260 | f-study@cosomil.com |
| Name | Affiliation | Role |
|---|---|---|
| Keiji Hanada, MD, Ph.D. | JA Onomichi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Medical University Hospital | Recruiting | Nagakute | Aichi-ken | Japan | ||
| Nagoya University Hospital |
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| Label | URL |
|---|---|
| Clinical trial registration record in the UMIN Clinical Trials Registry for UMIN000059647 | View source |
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Individual participant data will not be made publicly available.
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This is a nationwide, multicenter, prospective, single-arm interventional feasibility study. The study evaluates the integration of the Enzeavour Pancreatic Cancer assay into routine health checkups and cancer screening pathways in asymptomatic adults in Japan. The study uses a pragmatic implementation design with partial verification, in which initial diagnostic imaging is primarily performed in participants with a positive index test result, with targeted 12-month follow-up for pre-specified subgroups.
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Comparison of positivity rates and detection rates between the Enzeavour assay and conventional tumor markers, including CA19-9, overall and within the Enzeavour-positive subgroup. |
| Baseline through 12 months |
| Imaging Correlates of Assay Results | Comparative analysis of MRCP findings according to assay status and retrospective re-evaluation of baseline imaging in confirmed cancer cases. | Baseline through 12 months |
| Preliminary Longitudinal Performance Measures | Descriptive estimation of specificity and incidence rates for pancreatic and extra-pancreatic malignancies during follow-up. | 365 days after the index blood draw |
| Recruiting |
| Nagoya |
| Aichi-ken |
| Japan |
| Hiroshima University Hospital | Recruiting | Hiroshima | Hiroshima | Japan |
| JA Onomichi General Hospital | Recruiting | Onomichi | Hiroshima | Japan |
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| Obihiro Kosei Hospital | Recruiting | Obihiro | Hokkaido | Japan |
| Keijinkai Maruyama Clinic | Recruiting | Sapporo | Hokkaido | Japan |
| Teine Keijinkai Hospital | Recruiting | Sapporo | Hokkaido | Japan |
| Hotel Okura Kobe Clinic | Recruiting | Kobe | Hyōgo | Japan |
| Kobe University Hospital | Recruiting | Kobe | Hyōgo | Japan |
| Ibaraki Medical Center | Recruiting | Mito | Ibaraki | Japan |
| Mito Kyodo General Hospital | Recruiting | Mito | Ibaraki | Japan |
| Kagawa University Hospital | Recruiting | Kita-gun Miki-cho | Kagawa-ken | Japan |
| JA Health Management Center Atsugi | Recruiting | Atsugi | Kanagawa | Japan |
| Isehara Kyodo Hospital | Recruiting | Isehara | Kanagawa | Japan |
| St. Marianna University School of Medicine Hospital | Recruiting | Kawasaki | Kanagawa | Japan |
| JA Health Management Center Sagamihara | Recruiting | Sagamihara | Kanagawa | Japan |
| Kitasato University Hospital | Recruiting | Sagamihara | Kanagawa | Japan |
| Yokohama City University Medical Center | Recruiting | Yokohama | Kanagawa | Japan |
| Clinic Green House | Recruiting | Kochi | Kochi | Japan |
| Japanese RedCross Society Kochi Red Cross Hospital | Recruiting | Kochi | Kochi | Japan |
| Kochi Kenshin Clinic | Recruiting | Kochi | Kochi | Japan |
| Kyoto Industrial Health Association | Recruiting | Kyoto | Kyoto | Japan |
| Kyoto University Hospital | Recruiting | Kyoto | Kyoto | Japan |
| Matsusaka Medical Association | Recruiting | Matsusaka | Mie-ken | Japan |
| Mie Healthcare center | Recruiting | Tsu | Mie-ken | Japan |
| Mie University Hospital | Recruiting | Tsu | Mie-ken | Japan |
| Oita University Hospital | Recruiting | Yufu | Oita Prefecture | Japan |
| Nakagami General Chibana Clinic | Recruiting | Okinawa | Okinawa | Japan |
| Nakagami Hospital | Recruiting | Okinawa | Okinawa | Japan |
| Okinawa Health Promotion Foundation | Recruiting | Shimajiri-gun Haebaru-cho | Okinawa | Japan |
| NEO Healthcare GI Endoscopy Clinic Honmachi | Recruiting | Osaka | Osaka | Japan |
| Tane Clinic | Recruiting | Osaka | Osaka | Japan |
| Tane General Hospital | Recruiting | Osaka | Osaka | Japan |
| Jichi Medical University Saitama Medical Center | Recruiting | Saitama | Saitama | Japan |
| Shiga University of Medical Science Hospital | Recruiting | Ōtsu | Shiga | Japan |
| Seirei Hamamatsu General Hospital | Recruiting | Hamamatsu | Shizuoka | Japan |
| Seirei Preventive Health Care Center | Recruiting | Hamamatsu | Shizuoka | Japan |
| Medical Check Studio Tokyo Ginza Clinic | Recruiting | Chuo-ku | Tokyo | Japan |
| C'est la vie Shinbashi Clinic | Recruiting | Itabashi-ku | Tokyo | Japan |
| Nihon University Itabashi Hospital | Recruiting | Itabashi-ku | Tokyo | Japan |
| Koganei Tsurukame Clinic | Recruiting | Koganei | Tokyo | Japan |
| The Jikei University Hospital | Recruiting | Minato-ku | Tokyo | Japan |
| Miraza Shinjuku Tsurukame Clinic | Recruiting | Shinjuku-ku | Tokyo | Japan |
| Shinjuku Tsurukame Clinic | Recruiting | Shinjuku-ku | Tokyo | Japan |
| Tokyo Women's Medical University Hospital | Recruiting | Shinjuku-ku | Tokyo | Japan |
| Wakayama Medical University Hospital | Recruiting | Wakayama | Wakayama | Japan |
| Public Interest Incorporated Foundation Yamagata Health Promotion Organization | Recruiting | Yamagata | Yamagata | Japan |
| Yamagata University Hospital | Recruiting | Yamagata | Yamagata | Japan |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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