Pancreatic Cancer Screening Using the Enzeavour Assay in Japan

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Pancreatic Cancer Detection Rate [Time frame: Within 12 months after the index blood draw]

Secondary outcome measures (1)

• Positive Predictive Value of the Enzeavour Assay [Time frame: Within 12 months after the index blood draw]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Screening

Study locations

Japan · 48 centers

• Aichi Medical University Hospital — Nagakute
• Nagoya University Hospital — Nagoya
• Hiroshima University Hospital — Hiroshima
• JA Onomichi General Hospital — Onomichi
• Obihiro Kosei Hospital — Obihiro
• Keijinkai Maruyama Clinic — Sapporo
• Teine Keijinkai Hospital — Sapporo
• Hotel Okura Kobe Clinic — Kobe
• … and 40 more centers

Identifiers

NCT: NCT07605819 · A250007-T · JPNP23019 · UMIN000059647 · A250007-T

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗