Tokyo, Nov. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059647) titled 'The feasibility study for pancreatic cancer screening by plasma biomarker using Enzeavour Pancreatic Cancer Test' on Nov. 5.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Cosomil Inc.

Condition: Condition - Pancreatic cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 10000

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068160

Disclaimer: Curated by HT Syndication.