Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060126) titled 'A study on immune-related adverse events developing in malignant tumor patients treated with immune checkpoint inhibitors in our hospital' on April 1.

Study Type: Observational

Primary Sponsor: Institute - Saitama Medical University International Medical Center

Condition: Condition - immune-related adverse events Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Immune checkpoint molecules (PD-1, CTLA-4) expressed by T cells function to suppress the activation of T cells themselves, playing a role in stopping the runaway activation of T cells. PD-L1, the ligand for PD-1, is also one of the immune checkpoint molecules. When a target cell (such as a cancer cell) expresses PD-L1, it binds to PD-1 on the T cell, thereby suppressing T cell activation (attack). Immune checkpoint inhibitors (ICIs), which are antibody preparations targeting these immune checkpoints, activate T cells. Consequently, ICIs have become used in the treatment of malignant tumors. However, ICIs can sometimes cause autoimmune disease-like side effects, termed immune-related adverse events (irAEs), which have become a significant concern. The objective of this study is to clarify the characteristics of irAE, which is expected to contribute to future countermeasures against irAE. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients with malignant tumors who received treatment with immune checkpoint inhibitors Key exclusion criteria - none Target Size - 1000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2023 Year 10 Month 01 Day Anticipated trial start date - 2023 Year 10 Month 01 Day Last follow-up date - 2028 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068766

Disclaimer: Curated by HT Syndication.