Pancreatic Cancer Screening Using the Enzeavour Assay in Japan (ENZEAVOUR FS)

June 23, 2026 updated by: Cosomil, Inc.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
    • Aichi-ken
      • Nagakute, Aichi-ken, Japan
        • Recruiting
        • Aichi Medical University Hospital
      • Nagoya, Aichi-ken, Japan
        • Recruiting
        • Nagoya University Hospital
    • Hiroshima
      • Hiroshima, Hiroshima, Japan
        • Recruiting
        • Hiroshima University Hospital
      • Onomichi, Hiroshima, Japan
        • Recruiting
        • JA Onomichi General Hospital
        • Contact:
          • Keiji Hanada, MD, Ph.D.
        • Principal Investigator:
          • Keiji Hanada, MD, Ph.D.
    • Hokkaido
      • Obihiro, Hokkaido, Japan
        • Recruiting
        • Obihiro Kosei Hospital
      • Sapporo, Hokkaido, Japan
        • Recruiting
        • Keijinkai Maruyama Clinic
      • Sapporo, Hokkaido, Japan
        • Recruiting
        • Teine Keijinkai Hospital
    • Hyōgo
      • Kobe, Hyōgo, Japan
        • Recruiting
        • Hotel Okura Kobe Clinic
      • Kobe, Hyōgo, Japan
        • Recruiting
        • Kobe University Hospital
    • Ibaraki
      • Mito, Ibaraki, Japan
        • Recruiting
        • Ibaraki Medical Center
      • Mito, Ibaraki, Japan
        • Recruiting
        • Mito Kyodo General Hospital
    • Kagawa-ken
      • Kita-gun Miki-cho, Kagawa-ken, Japan
        • Recruiting
        • Kagawa University Hospital
    • Kanagawa
      • Atsugi, Kanagawa, Japan
        • Recruiting
        • JA Health Management Center Atsugi
      • Isehara, Kanagawa, Japan
        • Recruiting
        • Isehara Kyodo Hospital
      • Kawasaki, Kanagawa, Japan
        • Recruiting
        • St. Marianna University School of Medicine Hospital
      • Sagamihara, Kanagawa, Japan
        • Recruiting
        • Kitasato University Hospital
      • Sagamihara, Kanagawa, Japan
        • Recruiting
        • JA Health Management Center Sagamihara
      • Yokohama, Kanagawa, Japan
        • Recruiting
        • Yokohama City University Medical Center
    • Kochi
      • Kochi, Kochi, Japan
        • Recruiting
        • Clinic Green House
      • Kochi, Kochi, Japan
        • Recruiting
        • Japanese RedCross Society Kochi Red Cross Hospital
      • Kochi, Kochi, Japan
        • Recruiting
        • Kochi Kenshin Clinic
    • Kyoto
      • Kyoto, Kyoto, Japan
        • Recruiting
        • Kyoto University Hospital
      • Kyoto, Kyoto, Japan
        • Recruiting
        • Kyoto Industrial Health Association
    • Mie-ken
      • Matsusaka, Mie-ken, Japan
        • Recruiting
        • Matsusaka Medical Association
      • Tsu, Mie-ken, Japan
        • Recruiting
        • Mie University Hospital
      • Tsu, Mie-ken, Japan
        • Recruiting
        • Mie Healthcare center
    • Oita Prefecture
      • Yufu, Oita Prefecture, Japan
        • Recruiting
        • Oita University Hospital
    • Okinawa
      • Okinawa, Okinawa, Japan
        • Recruiting
        • Nakagami General Chibana Clinic
      • Okinawa, Okinawa, Japan
        • Recruiting
        • Nakagami Hospital
      • Shimajiri-gun Haebaru-cho, Okinawa, Japan
        • Recruiting
        • Okinawa Health Promotion Foundation
    • Osaka
      • Osaka, Osaka, Japan
        • Recruiting
        • NEO Healthcare GI Endoscopy Clinic Honmachi
      • Osaka, Osaka, Japan
        • Recruiting
        • Tane Clinic
      • Osaka, Osaka, Japan
        • Recruiting
        • Tane General Hospital
    • Saitama
      • Saitama, Saitama, Japan
        • Recruiting
        • Jichi Medical University Saitama Medical Center
    • Shiga
      • Ōtsu, Shiga, Japan
        • Recruiting
        • Shiga University of Medical Science Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan
        • Recruiting
        • Seirei Hamamatsu General Hospital
      • Hamamatsu, Shizuoka, Japan
        • Recruiting
        • Seirei Preventive Health Care Center
    • Tokyo
      • Chuo-ku, Tokyo, Japan
        • Recruiting
        • Medical Check Studio Tokyo Ginza Clinic
      • Itabashi-ku, Tokyo, Japan
        • Recruiting
        • C'est la vie Shinbashi Clinic
      • Itabashi-ku, Tokyo, Japan
        • Recruiting
        • Nihon University Itabashi Hospital
      • Koganei, Tokyo, Japan
        • Recruiting
        • Koganei Tsurukame Clinic
      • Minato-ku, Tokyo, Japan
        • Recruiting
        • The Jikei University Hospital
      • Shinjuku-ku, Tokyo, Japan
        • Recruiting
        • Tokyo Women's Medical University Hospital
      • Shinjuku-ku, Tokyo, Japan
        • Recruiting
        • Miraza Shinjuku Tsurukame Clinic
      • Shinjuku-ku, Tokyo, Japan
        • Recruiting
        • Shinjuku Tsurukame Clinic
    • Wakayama
      • Wakayama, Wakayama, Japan
        • Recruiting
        • Wakayama Medical University Hospital
    • Yamagata
      • Yamagata, Yamagata, Japan
        • Recruiting
        • Yamagata University Hospital
      • Yamagata, Yamagata, Japan
        • Recruiting
        • Public Interest Incorporated Foundation Yamagata Health Promotion Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Enzeavour Screening Pathway
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.
Diagnostic test: Enzeavour 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within 12 months after the index blood draw

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Within 12 months after the index blood draw

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Within 12 months after the index blood draw
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.
Baseline through 12 months
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.
Baseline through 12 months
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.
365 days after the index blood draw

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cosomil, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Keiji Hanada, MD, Ph.D., JA Onomichi General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A250007-T (Other Identifier: Kobe University Hospital Interventional Research Ethics Committee)
  • JPNP23019 (Other Grant/Funding Number: The New Energy and Industrial Technology Development Organization (NEDO))
  • UMIN000059647 (Registry Identifier: University hospital Medical Information Network (UMIN) Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made publicly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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