Pancreatic CancerENZEAVOUR FSNCT07605819
Pancreatic Cancer Screening Using the Enzeavour Assay in Japan
A study testing Enzeavour Pancreatic Cancer Assay in people with Pancreatic Cancer and Pancreatic Neoplasms, run by Cosomil, Inc. at 69 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Neoplasms
- What is being tested?
- Enzeavour Pancreatic Cancer Assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 69 sitesJapan
- Study dates
- 4 Feb 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
69 sites in 1 country. Contact the study team or a site near you to ask about taking part.
69 sites in 1 country
Japan69 sites, 69 recruiting
- Recruiting
JA Health Management Center Atsugi
Atsugi, Kanagawa
- Recruiting
Chiba University Hospital
Chiba, Chiba
- Recruiting
Medical Check Studio Tokyo Ginza Clinic
Chuo-ku, Tokyo
- Recruiting
Fukuoka University Hospital
Fukuoka, Fukuoka
- Recruiting
Wellness Tenjin
Fukuoka, Fukuoka
- Recruiting
Health Checkup Center Kitade
Gobō, Wakayama
- Recruiting
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka
- Recruiting
Seirei Preventive Health Care Center
Hamamatsu, Shizuoka
- Recruiting
Hiroshima University Hospital
Hiroshima, Hiroshima
- Recruiting
Iida Municipal Hospital
Iida, Nagano
- Recruiting
Isehara Kyodo Hospital
Isehara, Kanagawa
- Recruiting
Matsunami General Hospital
Kasamatsuchō, Gifu
- Recruiting
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa
- Recruiting
Kagawa University Hospital
Kita-gun Miki-cho, Kagawa-ken
- Recruiting
Hotel Okura Kobe Clinic
Kobe, Hyōgo
- Recruiting
Kobe University Hospital
Kobe, Hyōgo
- Recruiting
Sano Hospital
Kobe, Hyōgo
- Recruiting
Clinic Green House
Kochi, Kochi
- Recruiting
Japanese RedCross Society Kochi Red Cross Hospital
Kochi, Kochi
- Recruiting
Kochi Kenshin Clinic
Kochi, Kochi
- Recruiting
Koganei Tsurukame Clinic
Koganei, Tokyo
- Recruiting
Junpukai Health Maintenance Center Kurashiki
Kurashiki, Okayama-ken
- Recruiting
Kawasaki Medical School General Medical Center
Kurashiki, Okayama-ken
- Recruiting
Kyoto Industrial Health Association
Kyoto, Kyoto
- Recruiting
Kyoto University Hospital
Kyoto, Kyoto
- Recruiting
Mitsubishi Kyoto Hospital
Kyoto, Kyoto
- Recruiting
Matsusaka Chuo General Hospital
Matsusaka, Mie-ken
- Recruiting
Matsusaka Medical Association
Matsusaka, Mie-ken
- Recruiting
Dokkyo Medical University Hospital
Mibu, Tochigi
- Recruiting
The Jikei University Hospital
Minato-ku, Tokyo
- Recruiting
C'est la vie Shinbashi Clinic
Minato-Ku, Tokyo
- Recruiting
Ibaraki Medical Center
Mito, Ibaraki
- Recruiting
Mito Kyodo General Hospital
Mito, Ibaraki
- Recruiting
Aichi Medical University Hospital
Nagakute, Aichi-ken
- Recruiting
Chunichi Hospital
Nagoya, Aichi-ken
- Recruiting
Nagoya University Hospital
Nagoya, Aichi-ken
- Recruiting
Obihiro Kosei Hospital
Obihiro, Hokkaido
- Recruiting
Junpukai Health Maintenance Center Daianji
Okayama, Okayama-ken
- Recruiting
Junpukai Health Maintenance Center
Okayama, Okayama-ken
- Recruiting
Nakagami General Chibana Clinic
Okinawa, Okinawa
- Recruiting
Nakagami Hospital
Okinawa, Okinawa
- Recruiting
JA Onomichi General Hospital
Onomichi, Hiroshima
Keiji Hanada, MD, Ph.D.
Keiji Hanada, MD, Ph.D.
- Recruiting
Medical Research Institute KITANO HOSPITAL,PIIF Tazuke-Kofukai
Osaka, Osaka
- Recruiting
NEO Healthcare GI Endoscopy Clinic Honmachi
Osaka, Osaka
- Recruiting
Tane Clinic
Osaka, Osaka
- Recruiting
Tane General Hospital
Osaka, Osaka
- Recruiting
Shiga University of Medical Science Hospital
Ōtsu, Shiga
- Recruiting
JA Health Management Center Sagamihara
Sagamihara, Kanagawa
- Recruiting
Kitasato University Hospital
Sagamihara, Kanagawa
- Recruiting
Jichi Medical University Saitama Medical Center
Saitama, Saitama
- Recruiting
Keijinkai Maruyama Clinic
Sapporo, Hokkaido
- Recruiting
NTT East Sapporo Hospital
Sapporo, Hokkaido
- Recruiting
Teine Keijinkai Hospital
Sapporo, Hokkaido
- Recruiting
Tonan Hospital
Sapporo, Hokkaido
- Recruiting
Okinawa Health Promotion Foundation
Shimajiri-gun Haebaru-cho, Okinawa
- Recruiting
Miraza Shinjuku Tsurukame Clinic
Shinjuku-ku, Tokyo
- Recruiting
Shinjuku Tsurukame Clinic
Shinjuku-ku, Tokyo
- Recruiting
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo
- Recruiting
Nihon University Itabashi Hospital
tabashi City, Tokyo
- Recruiting
KKR Takamatsu Hospital
Takamatsu, Kagawa-ken
- Recruiting
Mie Healthcare center
Tsu, Mie-ken
- Recruiting
Mie University Hospital
Tsu, Mie-ken
- Recruiting
Wakayama Health Checkup Clinic Kitade
Wakayama, Wakayama
- Recruiting
Wakayama Medical University Hospital
Wakayama, Wakayama
- Recruiting
Public Interest Incorporated Foundation Yamagata Health Promotion Organization
Yamagata, Yamagata
- Recruiting
Yamagata University Hospital
Yamagata, Yamagata
- Recruiting
Yokohama City University Medical Center
Yokohama, Kanagawa
- Recruiting
Yokohama Rosai Hospital
Yokohama, Kanagawa
- Recruiting
Oita University Hospital
Yufu, Oita Prefecture
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Cancer, Pancreatic Neoplasms
- Being tested
- Enzeavour Pancreatic Cancer Assay
- Keywords
- pancreatic cancer screening, liquid biopsy, blood-based biomarker, early detection, Enzeavour, single-molecule enzyme activity
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzeavour Pancreatic Cancer AssayDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Enzeavour Pancreatic Cancer Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 months after the index blood draw
Secondary 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.
Measured: Within 12 months after the index blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start4 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cosomil, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keiji Hanada, MD, Ph.D., Principal investigator, JA Onomichi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605819
- Sponsor's protocol ID
- A250007-T
- Other IDs
- JPNP23019, UMIN000059647, A250007-T
- Acronym
- ENZEAVOUR FS
- Status last verified
- Oct 2026
- First submitted
- 11 May 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Cancer Screening Using Single-Molecule Enzyme Activity-Based Liquid Biopsy, Enzeavour: A Single-Arm Interventional Feasibility Study Protocol in Japan
- ClinicalTrials.gov ID
- NCT07605819
- Acronym / sponsor ID
- ENZEAVOUR FS / A250007-T
- Conditions
- Pancreatic Cancer, Pancreatic Neoplasms
- Keywords
- pancreatic cancer screening, liquid biopsy, blood-based biomarker, early detection, Enzeavour, single-molecule enzyme activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Cosomil, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enzeavour Screening Pathway | Experimental | Diagnostic Test: Enzeavour Pancreatic Cancer AssayParticipants 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enzeavour Pancreatic Cancer AssayA 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. | Diagnostic test | Enzeavour Screening Pathway |
Primary outcome
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.
1 secondary outcome
Positive Predictive Value of the Enzeavour Assay
Time frame: Within 12 months after the index blood draw
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Clinical trial registration record in the UMIN Clinical Trials Registry for UMIN000059647Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keiji Hanada, MD, Ph.D. principal investigator
JA Onomichi General Hospital
69 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enzeavour Pancreatic Cancer Assay in people with Pancreatic Cancer and Pancreatic Neoplasms, run by Cosomil, Inc. at 69 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Kagami, Ph.D. (+81-3-6823-2260, f-study@cosomil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic Cancer Detection Rate (time frame: Within 12 months after the index blood draw). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.