Tokyo, May 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060634) titled 'Effects of immune checkpoint inhibitor-related pancreatic injury on pancreatic function: a multicenter retrospective observational study' on May 1.

Study Type: Observational

Primary Sponsor: Institute - Kobe University

Condition: Condition - Immune checkpoint inhibitor-related pancreatic injury (ICI-PI) Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To retrospectively evaluate the incidence of pancreatic atrophy and new-onset diabetes or worsening of glucose tolerance in patients with immune checkpoint inhibitor-related pancreatic injury (ICI-PI). Basic objectives2 - Others

Eligibility: Age-lower limit - 128 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - [Case-enriched cohort (multicenter; patients with ICI-PI)] 1. Patients who developed immune checkpoint inhibitor-related pancreatic injury (ICI-PI) after receiving immune checkpoint inhibitors (ICIs) at participating institutions, including collaborating centers, between September 2014 and April 2019 2. Patients whose clinical course and outcome data are available from medical records 3. Patients aged 18 years or older at the start of ICI treatment [Comparative cohort (single-center consecutive cohort; source population for comparative analyses)] 1. Consecutive patients who received immune checkpoint inhibitors (ICIs) at Kobe University Hospital between September 2014 and April 2019 2. Patients whose clinical course and outcome data are available from medical records 3. Patients aged 18 years or older at the start of ICI treatment Key exclusion criteria - Patients who declined participation via the opt-out process following public disclosure of the study information Target Size - 274

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 28 Day Anticipated trial start date - 2026 Year 05 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069351

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