UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059647 |
|---|---|
| Receipt number | R000068160 |
| Scientific Title | The feasibility study for pancreatic cancer screening by plasma biomarker using Enzeavour Pancreatic Cancer Test: A Single-Arm Intervention |
| Date of disclosure of the study information | 2025/11/05 |
| Last modified on | 2025/11/05 14:46:44 |
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Basic information
Public title
The feasibility study for pancreatic cancer screening by plasma biomarker using Enzeavour Pancreatic Cancer Test
Acronym
Feasibility Study of Enzeavour
Scientific Title
The feasibility study for pancreatic cancer screening by plasma biomarker using Enzeavour Pancreatic Cancer Test: A Single-Arm Intervention
Scientific Title:Acronym
Feasibility Study of Enzeavour
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This feasibility study is intended to support the implementation of a future large randomized controlled trial (RCT) evaluating the utility of the Enzeavour Pancreatic Cancer Test (the "Study Test") for pancreatic cancer screening. By conducting this feasibility study, we aim to confirm the pancreatic cancer detection rate and the biomarker positivity rate, and to obtain data necessary for sample size determination in the subsequent RCT.
Primary Objective
To evaluate the detection rate of pancreatic cancer in health checkups/screening when using the Study Test. Only participants who receive a confirmed diagnosis of pancreatic cancer within 12 months of the blood draw will be classified as "confirmed pancreatic cancer cases" for analysis.
Secondary Objective
To evaluate the positive predictive value (PPV) of the Study Test for pancreatic cancer.
Exploratory Objectives
To enable a more comprehensive assessment of the clinical utility of the Study Test, the following exploratory objectives are set:
1. To evaluate the association between Study Test results and pancreatic diseases and/or their risk factors.
2. To evaluate the association between Study Test results and existing biomarkers and imaging findings.
3. To follow the 365-day outcomes of false-negative and false-positive cases to generate insights into the longer-term performance of the Study Test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The detection rate of pancreatic cancer in health checkups/screening when using Enzeavour Pancreatic Cancer Test
Key secondary outcomes
The positive predictive value (PPV) of Enzeavour Pancreatic Cancer Test for pancreatic cancer
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Primary screening will use the Enzeavour Pancreatic Cancer Test.
Secondary screening will use diagnostic imaging (MRI/MRCP, EUS, or contrast-enhanced CT), selected at the investigator's discretion for each participant.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Men and women undergoing specific health checkups (Tokutei kenshin), cancer screening, workplace health examinations, or comprehensive health checkups at participating medical and screening institutions (collectively referred to in this study as "health checkups/screenings").
2. Willing to undergo testing with the Enzeavour Pancreatic Cancer Test.
3. Able to provide written informed consent to participate in this study.
4. Willing to undergo detailed diagnostic imaging if the Study Test result is positive.
Key exclusion criteria
1. History of any of the following diagnoses prior to the health checkup/screening:
- Pancreatic cancer
- Mucinous cystic neoplasm (MCN)
- Solid pseudopapillary neoplasm (SPN) of the pancreas
- Pancreatic neuroendocrine tumor (PNET)
2. History of pancreatic resection (partial or total).
3. Prior vasovagal episodes or similar reactions during blood draws (phlebotomy).
4. Suspected impaired capacity to provide informed consent (e.g., dementia requiring treatment, psychiatric disorder requiring treatment).
5. Any other condition that, in the judgment of the investigators, makes the individual unsuitable for this study.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Keiji |
| Middle name | |
| Last name | Hanada |
Organization
JA Onomichi General Hospital
Division name
Gastroenterology
Zip code
7228508
Address
Hirahara 1-10-23, Onomichi-shi, Hiroshima
TEL
0848-22-8111
k.hanada@onomichi-gh.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Kagami |
Organization
Cosomil Inc.
Division name
CEO
Zip code
113-8485
Address
Entrepreneur Lab, South Clinical Research Bldg., 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-6823-2260
Homepage URL
f-study@cosomil.com
Sponsor or person
Institute
Cosomil Inc.
Institute
Department
Personal name
Funding Source
Organization
Cosomil Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital
Address
Kusunokicho7-5-2, Chuo-ku, Kobe-shi, Hyougo
Tel
078-382-6669
kainyu@med.kobe-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068160
