UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061258 |
|---|---|
| Receipt number | R000069608 |
| Scientific Title | A multicenter prospective observational study exploring soluble factors in pleural effusion that can predict the therapeutic efficacy of immune checkpoint inhibitors in pleural mesothelioma |
| Date of disclosure of the study information | 2026/04/14 |
| Last modified on | 2026/04/14 16:09:51 |
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Basic information
Public title
Exploratory study of predictive biomarkers for treatment response using pleural effusion in pleural mesothelioma
Acronym
Pleural mesothelioma study
Scientific Title
A multicenter prospective observational study exploring soluble factors in pleural effusion that can predict the therapeutic efficacy of immune checkpoint inhibitors in pleural mesothelioma
Scientific Title:Acronym
Pleural effusion study in pleural mesothelioma
Region
| Japan |
Condition
Condition
Pleural mesothelioma and other diseases associated with pleural effusion
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify soluble biomarkers in pleural effusion from patients with pleural mesothelioma that predict response to immune checkpoint inhibitors.
Basic objectives2
Others
Basic objectives -Others
Identification of predictive biomarkers for therapeutic response to the drug
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between soluble factor levels in pleural effusion and response to immune checkpoint inhibitors in pleural mesothelioma
Key secondary outcomes
Exploration of predictive biomarkers for immune checkpoint inhibitor-induced immune-related adverse events in pleural effusion from pleural mesothelioma.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Riki |
| Middle name | |
| Last name | Okita |
Organization
NHO Yamaguchi Ube Medical Center
Division name
Clinical Research
Zip code
755-0241
Address
Higashikiwa 685, Ube, Yamaguchi
TEL
0836582300
riki0716okita@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Riki |
| Middle name | |
| Last name | Okita |
Organization
NHO Yamaguchi Ube Medical Center
Division name
Clinical Research
Zip code
755-0241
Address
Higashikiwa 685, Ube, Yamaguchi
TEL
0836582300
Homepage URL
riki0716okita@yahoo.co.jp
Sponsor or person
Institute
NHO Yamaguchi Ube Medical Center
Institute
Department
Personal name
Funding Source
Organization
Collaborative Clinical Research within the National Hospital Organization (NHO)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Headquarters
Address
2-5-21 Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5075
700-kenkyu@mail.hosp.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R7-EBM(Respiratory cancer)-02
Org. issuing International ID_1
Collaborative Clinical Research within the National Hospital Organization (NHO)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立病院機構山口宇部医療センター、他
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Soluble factors in pleural effusion
Management information
Registered date
| 2026 | Year | 04 | Month | 14 | Day |
Last modified on
| 2026 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069608
