臨床研究等提出・公開システム

Japanese

Date of registration	May. 28, 2026
Last modified on	June. 24, 2026
Trial ID	jRCT1050260052

Scientific Title	Pancreatic Cancer Screening Using Single-Molecule Enzyme Activity-Based Liquid Biopsy, Enzeavour: A Single-Arm Interventional Feasibility Study Protocol in Japan (ENZEAVOUR Feasibility Study)
Public Title	Pancreatic Cancer Screening Using the Enzeavour Assay in Japan (ENZEAVOUR-FS)

Contact for Scientific Queries	Name	Hanada Keiji
	Affiliation	JA Onomichi General Hospital
	Address	1-10-23 Hirahara, Onomichi-shi, Hiroshima 722-8508 Japan
	Telephone	+81-848-22-8111
	E-mail	k.hanada@onomichi-gh.jp
Contact for Public Queries	Name	Kagami Yu
	Affiliation	Cosomil, Inc.
	Address	Entrepreneur Lab 215, South Research Building, The University of Tokyo 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8485 Japan
	Telephone	+81-3-6823-2260
	E-mail	f-study@cosomil.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 05, 2025
Actual date of first enrollment		Feb. 10, 2026
Target sample size		10000
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	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
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pancreatic cancer, Pancreatic neoplasms
Intervention(s)		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.
Health Condition(s) Keyword		pancreatic cancer screening, liquid biopsy, blood-based biomarker, early detection, Enzeavour, single-molecule enzyme activity
Intervention(s) Keyword		Early Detection of Cancer, Biomarkers, Tumor, Diagnostic Imaging, Follow-Up Studies
Health Condition(s) Code		D010190
Intervention(s) Code		D055815, D015179, D003694, D005500
Primary Outcome(s)		Pancreatic Cancer Detection Rate
Secondary Outcome(s)		Positive Predictive Value of the Enzeavour Assay

Primary Sponsor	Cosomil, Inc.

Source of Monetary Support / Secondary Sponsor	Cosomil, Inc.
Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Kobe University Hospital Interventional Research Ethics Committee
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe-shi, Hyogo 650-0017 Japan, Hyogo
Telephone	+81-78-382-6669
E-Mail	kainyu@med.kobe-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 24, 2025

Plan to share IPD	No

Secondary ID(s)	UMIN000059647
Issuing Authority	UMIN-CTR

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	June. 24, 2026	(this page)	Changes
1	May. 28, 2026	Detail

List of change history