Tokyo, April 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061258) titled 'Exploratory study of predictive biomarkers for treatment response using pleural effusion in pleural mesothelioma' on April 14.
Study Type:
Observational
Primary Sponsor:
Institute - NHO Yamaguchi Ube Medical Center
Condition:
Condition - Pleural mesothelioma and other diseases associated with pleural effusion
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To identify soluble biomarkers in pleural effusion from patients with pleural mesothelioma that predict response to immune checkpoint inhibitors.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients histologically diagnosed with pleural mesothelioma or patients suspected of having pleural mesothelioma based on imaging findings.
2. Patients with pleural effusion who are scheduled to undergo pleural effusion sampling.
3. Patients aged 18 years or older who provide written informed consent, or whose legally authorized representative provides written informed consent.
4. Patients who, at the time of registration, are considered eligible for immune checkpoint inhibitor therapy if pleural mesothelioma is confirmed by pathological diagnosis.
Key exclusion criteria - 1. Patients who are judged to be ineligible for immune checkpoint inhibitor therapy at the time of screening.
2. Patients with acute empyema or pneumothorax (patients with iatrogenic pneumothorax associated with thoracentesis may be enrolled).
3. Patients who are judged by the principal investigator or sub-investigators to be inappropriate for participation in this study.
Target Size - 150
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 01 Month 19 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2030 Year 10 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069608
Disclaimer: Curated by HT Syndication.