Pancreatic Cancer, Pancreatic Neoplasms
Conditions
Keywords
pancreatic cancer screening, liquid biopsy, blood-based biomarker, early detection, Enzeavour, single-molecule enzyme activity
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTEnzeavour Pancreatic Cancer Assay
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.
Sponsors
Cosomil, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pancreatic Cancer Detection Rate | Within 12 months after the index blood draw | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Predictive Value of the Enzeavour Assay | Within 12 months after the index blood draw | 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. |
Countries
Japan
Contacts
CONTACTYu Kagami, Ph.D.
PRINCIPAL_INVESTIGATORKeiji Hanada, MD, Ph.D.
JA Onomichi General Hospital
Outcome results
None listed