Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061297) titled 'Skeletal muscle-based treatment strategies for immune checkpoint inhibitor' on June 1.
Study Type:
Observational
Primary Sponsor:
Institute - Hamamatsu University School of Medicine
Condition:
Condition - Urothelial carcinoma
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - We investigated patients with urothelial carcinoma receiving treatment with immune checkpoint inhibitors, focusing on: (1) body composition related to sarcopenia (such as skeletal muscle mass, muscle strength, and muscle quality), (2) skeletal muscle-related factors involved in immune regulation; (3) immune status related to resistance to ICI therapy (rate of increase in CD8+ T cells following treatment, proportion of regulatory T cells and bone marrow-derived suppressor cells, expression of immune checkpoint molecules on CD8+ T cells, etc.); and (4) ICI treatment outcomes (treatment efficacy, adverse effects, etc.), with the aim of clarifying the relationships among these factors.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients starting treatment with immune checkpoint inhibitors
Patients diagnosed with urothelial carcinoma
Patients who have provided informed consent to participate in this study by signing a consent form
Patients aged 18 years or older
Key exclusion criteria - Individuals from whom written consent could not be obtained
Other patients deemed unsuitable by the attending physician
Target Size - 90
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 10 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2030 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070054
Disclaimer: Curated by HT Syndication.
