Tokyo, May 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061530) titled 'Development of Personalized Medicine through Genomic Analysis of Acquired Inflammatory Diseases and Immunodeficiencies Using a National Registry' on May 11.
Study Type:
Observational
Primary Sponsor:
Institute - Yokohama City University Graduate School of Medicine
Condition:
Condition - Patients with suspected acquired autoinflammatory diseases and autoimmune diseases
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - This study aims to clarify the role of acquired genetic alterations in unexplained or treatment-refractory inflammatory conditions and to establish a foundation for personalized medicine.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1) Age 18 years or older
2) No restriction on sex
3) Patients with refractory inflammatory findings or those suspected of having an inflammatory disease by the treating physician
4) Written informed consent obtained for participation in this study
Key exclusion criteria - 1) Patients in whom inflammation is clearly attributable to infection or malignancy
2) Patients whose inflammation can be explained by a known inflammatory or autoimmune disease fulfilling established international diagnostic criteria
3) Patients with an expected life expectancy of less than 1 year (e.g., terminal cancer)
Target Size - 300
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 07 Day
Date of IRB - 2026 Year 02 Month 03 Day
Anticipated trial start date - 2026 Year 05 Month 16 Day
Last follow-up date - 2037 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069953
Disclaimer: Curated by HT Syndication.
