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NCT Number: NCT07605819

Pancreatic Cancer Screening Using the Enzeavour Assay in 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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aichi Medical University Hospital, Nagakute, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pancreatic Cancer Detection Rate

    Time frame: 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 outcomes

  1. Positive Predictive Value of the Enzeavour Assay

    Time frame: 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.

Other outcomes

  1. Detection Rates of Other Pancreatic Diseases and High-Risk Radiological Findings

    Time frame: Within 12 months after the index blood draw

    Descriptive analysis of detection rates for various pancreatic diseases and high-risk radiological findings identified during diagnostic work-up and follow-up.

  2. Comparison With Conventional Tumor Markers

    Time frame: Baseline through 12 months

    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.

  3. Imaging Correlates of Assay Results

    Time frame: Baseline through 12 months

    Comparative analysis of MRCP findings according to assay status and retrospective re-evaluation of baseline imaging in confirmed cancer cases.

  4. Preliminary Longitudinal Performance Measures

    Time frame: 365 days after the index blood draw

    Descriptive estimation of specificity and incidence rates for pancreatic and extra-pancreatic malignancies during follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Kagami, Ph.D.

CONTACT

[email protected]

+81-3-6823-2260

Sponsors and collaborators

Lead sponsor

Cosomil, Inc.

Industry

Registry information

Official study title

Pancreatic Cancer Screening Using Single-Molecule Enzyme Activity-Based Liquid Biopsy, Enzeavour: A Single-Arm Interventional Feasibility Study Protocol in Japan

Acronym: ENZEAVOUR FS

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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