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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Enzeavour Pancreatic Cancer Assay
Diagnostic testA 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.
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: Enzeavour Screening PathwayExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Within 12 months after the index blood drawSecondary outcomes
1
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.
Time frame
Within 12 months after the index blood drawOther outcomes
1
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.
Time frame
Within 12 months after the index blood draw2
Comparison With Conventional Tumor Markers
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.
Time frame
Baseline through 12 months3
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.
Time frame
Baseline through 12 months4
Preliminary Longitudinal Performance Measures
Descriptive estimation of specificity and incidence rates for pancreatic and extra-pancreatic malignancies during follow-up.
Time frame
365 days after the index blood drawSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov