Clinical Trial: Comparative Study of Specimen Adequacy Between Primary and Metastatic Lesions in Endoscopic Ultrasound-Guided Fine-Needle Biopsy for Pancreatic Masses Aimed at Comprehensive Genomic Profiling (Japan)

Tokyo, April 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061355) titled 'Comparative Study of Specimen Adequacy Between Primary and Metastatic Lesions in Endoscopic Ultrasound-Guided Fine-Needle biopsy for Pancreatic Masses Aimed at Comprehensive Genomic Profiling' on April 22.

Study Type: Observational

Primary Sponsor: Institute - Okayama university

Condition: Condition - pancreatic lesions Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - In patients with pancreatic lesions, this study aims to determine the optimal target for EUS-FNB when comprehensive genomic profiling is planned by comparing the success rate of meeting CGP requirements between primary lesion and metastatic lesion specimens obtained during the same EUS-FNB session. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who visit the study institution between the date of approval by the head of the institution and June 30, 2028 Patients with pancreatic mass lesions who have both primary and metastatic lesions amenable to EUS-FNB and are scheduled to undergo comprehensive genomic profiling Patients from whom written informed consent can be obtained directly based on their own free will Patients aged 18 years or older at the time of consent Key exclusion criteria - Patients with a performance status of 3-4 Patients with a bleeding tendency or a platelet count <50000 Patients receiving two or more antithrombotic agents Patients in whom no safe puncture route is available due to inability to visualize the lesion by EUS or due to intervening vessels Pregnant women Patients from whom written informed consent could not be obtained based on their own free will after receiving a full explanation of the study Patients deemed inappropriate for participation by the principal investigator or sub-investigators for any other reason Target Size - 22

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 02 Month 05 Day Date of IRB - 2025 Year 03 Month 28 Day Anticipated trial start date - 2025 Year 03 Month 28 Day Last follow-up date - 2029 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070200

Disclaimer: Curated by HT Syndication.