NCT07605819 Pancreatic Cancer Screening Using the Enzeavour Assay in Japan
| NCT ID | NCT07605819 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cosomil, Inc. |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2026-02-04 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10,000 participants in total. It began in 2026-02-04 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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
Contact & Investigator
Keiji Hanada, MD, Ph.D.
PRINCIPAL INVESTIGATOR
JA Onomichi General Hospital
Frequently Asked Questions
Who can join the NCT07605819 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07605819 currently recruiting?
Yes, NCT07605819 is actively recruiting participants. Contact the research team at f-study@cosomil.com for enrollment information.
Where is the NCT07605819 trial being conducted?
This trial is being conducted at Nagakute, Japan, Nagoya, Japan, Hiroshima, Japan, Onomichi, Japan and 11 additional locations.
Who is sponsoring the NCT07605819 clinical trial?
NCT07605819 is sponsored by Cosomil, Inc.. The principal investigator is Keiji Hanada, MD, Ph.D. at JA Onomichi General Hospital. The trial plans to enroll 10,000 participants.
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