Tokyo, Sept. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062830) titled 'Elucidating mechanisms of hostmicrobiome interaction in cholangiocarcinoma development' on Sept. 5.

Study Type: Observational

Primary Sponsor: Institute - Shinshu university

Condition: Condition - biliary tract disease Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - WP1 Identification of a CCA-Associated Microbiome Signature This aim is to comprehensively identify characteristic alterations across the microbiome, metabolome, and host genome in patients with cholangiocarcinoma (CCA). WP2 Functional Analysis of Candidate Bacteria using "Cholangiocyte organoid model" This aim will validate the pathogenic potential of candidate bacteria identified in WP1 by assessing their direct impact on cholangiocytes in a sophisticated in vitro model. Basic objectives2 - Others

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Individuals aged 20 or older who are clinically suspected of having biliary tract cancer, present with a malignant stricture in any part of the biliary tract and suspected impaired bile outflow, and are undergoing ERCP. Individuals aged 20 or older undergoing ERCP for impaired bile outflow due to common bile duct stones, or for biliary strictures associated with benign biliary stricture, chronic pancreatitis, or liver disease. Key exclusion criteria - Individuals meeting the diagnostic criteria for cholangitis (Tokyo Guidelines 2018) [6]. Individuals with a history of sphincterotomy or biliary stent placement. Individuals who received antibiotics within the one month prior to the ERCP procedure. Individuals who received anticancer drugs within the one month prior to the ERCP procedure. Individuals otherwise deemed unsuitable for study participation by the principal investigator. Target Size - 200

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 07 Month 01 Day Date of IRB - 2026 Year 07 Month 06 Day Anticipated trial start date - 2026 Year 07 Month 20 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071922

Disclaimer: Curated by HT Syndication.