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Exploratory study of predictive biomarkers for treatment response using pleural effusion in pleural mesothelioma

A multicenter prospective observational study exploring soluble factors in pleural effusion that can predict the therapeutic efficacy of immune checkpoint inhibitors in pleural mesothelioma - Pleural effusion study in pleural mesothelioma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000061258
Enrollment
150
Registered
2026-04-14
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural mesothelioma and other diseases associated with pleural effusion

Interventions

None listed

Sponsors

NHO Yamaguchi Ube Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Association between soluble factor levels in pleural effusion and response to immune checkpoint inhibitors in pleural mesothelioma

Secondary

MeasureTime frame
Exploration of predictive biomarkers for immune checkpoint inhibitor-induced immune-related adverse events in pleural effusion from pleural mesothelioma.

Countries

Japan

Contacts

Public ContactRiki Okita

NHO Yamaguchi Ube Medical Center Clinical Research

riki0716okita@yahoo.co.jp0836582300

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026