Tokyo, May 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061595) titled 'Molecular, Cellular, and Spatial Analysis of Granulomas in Crohn's Disease' on May 25.

Study Type: Observational

Primary Sponsor: Institute - Kitasato University Kitasato Institute Hospital

Condition: Condition - Crohn's Disease Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - This study aims to elucidate the following three aspects of granulomas formed in intestinal tissues and regional lymph nodes of patients with Crohn's disease: 1. To identify microbial-derived and host-derived antigens within granulomas and their surrounding tissues. 2. To investigate host response abnormalities in granulomas within and between patients. 3. To extract mechanistic features of host response abnormalities related to phagocytosis, antigen processing, and inflammatory regulation. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who visited Kitasato University Kitasato Institute Hospital and meet all of the following criteria: 1. Patients aged 18 years or older with a diagnosis of Crohn's disease 2. Patients from whom tissue specimens have been obtained by surgical resection or endoscopic biopsy 3. Patients in whom granuloma formation has been pathologically confirmed, and whose residual tissue specimens are preserved after completion of diagnostic procedures Key exclusion criteria - Patients who meet any of the following criteria 1. Patients from whom written informed consent cannot be obtained 2. Patients deemed unsuitable for study participation by the principal investigator Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 20 Day Date of IRB - 2026 Year 05 Month 12 Day Anticipated trial start date - 2026 Year 05 Month 25 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=R000070454

Disclaimer: Curated by HT Syndication.