Pancreatic Cancer Screening Using the Enzeavour Assay in Japan

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

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

Вторичные конечные точки (1)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Япония · 48 центров

• 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
• … и ещё 40 центров

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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