UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038709 |
|---|---|
| Receipt number | R000044132 |
| Scientific Title | A multicenter, prospective feasibility study for definite diagnosis of malignant pleural mesothelioma by pleural effusion cytopathology |
| Date of disclosure of the study information | 2019/11/28 |
| Last modified on | 2026/06/03 22:11:09 |
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Basic information
Public title
MesoCyto Study
Acronym
MesoCyto Study
Scientific Title
A multicenter, prospective feasibility study for definite diagnosis of malignant pleural mesothelioma by pleural effusion cytopathology
Scientific Title:Acronym
Definite Diagnosis of Mesothelioma by Pleural Effusion Cytopathology
Region
| Japan |
Condition
Condition
Malignant Pleural Mesothelioma
Classification by specialty
| Pneumology | Chest surgery | Laboratory medicine |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the feasibility of difinite diagnosis with malignant pleural mesothelioma through cytopathology.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic specificity of pleural effusion examination
Key secondary outcomes
Positive predictive value of cytology and diagnostic concordance rates by histological subtype of MPM (epithelial, biphasic, and sarcomatous)
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)untreated
2)supicious with malignant pleural mesothelioma based on radiological findings
3)pleural effusion examination and pleural biopsy are needed to obtain definitive diagnosis
4)pleurocentesis could be safety done
5)pleural biopsy under general anesthesia could be safety done
6)adult
7)written informed concent of this study
Key exclusion criteria
1)pleural biopsy was already done prior to this study
2)complicated other malignancies
3)complicated other intrathoracic disease(empyema, pleuritis)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Seiki |
| Middle name | |
| Last name | Hasegawa |
Organization
Hyogo College of Medicine
Division name
Department of Thoracic Surgery
Zip code
6638501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6885
hasegawa@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Hashimoto |
Organization
Hyogo College of Medicine
Division name
Department of Thoracic Surgery
Zip code
6638501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6885
Homepage URL
kogekogemasaki@gmail.com
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukuoka University, University of Occupational and Environmental Health
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College of Medicine
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, 6638501 Japan
Tel
0798-45-6885
kogekogemasaki@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S3117504X26000410
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S3117504X26000410
Number of participants that the trial has enrolled
50
Results
Of the 50 enrolled patients, histological examination confirmed PM in 42 patients. Whereas in pleural effusion cytology, 29 patients met the diagnostic criteria of PM, 7 patients did not meet the criteria, and 13 patients did not observe atypical cells. All 29 cytologically positive patients were histologically diagnosed as PM, and 8 histologically negative patients did not meet the criteria
of pleural effusion cytology, therefore the specificity of pleural effusion cytology was 100%.
Results date posted
| 2026 | Year | 06 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 05 | Month | 22 | Day |
Baseline Characteristics
We included patients with pleural effusion and suspected PM scheduled for thoracentesis and pleural biopsy. Both pleural effusion cytology including cell block and pleural histology were independently performed and compared to assess the diagnostic reliability of pleural effusion cytology.
Participant flow
This was a prospective, open-label, single-arm study aimed at evaluating the diagnostic accuracy of pleural effusion cytology in patients with pleural effusion and suspected PM. Eligible patients who provided written informed consent underwent thoracentesis as the initial procedure, with subsequent pleural effusion cytology analysis. Pleural biopsy was conducted within one month of the
thoracentesis. The diagnoses based on pleural effusion cytology and histology was determined independently.
Adverse events
A total of 50 cases were enrolled between December 1, 2019, and October 20, 2021, distributed across Hyogo Medical University (42 cases), Fukuoka University (7 cases), and the University of Occupational and Environmental Health (1 case). The characteristics of the 50 cases are summarized in Table 1.
Among the 50 patients, 46 were men (92%), with a median age of 71.5 years (ranging from 53 to 93 years), and 31 patients (62%) presented symptoms on the right side. Asbestos exposure history was noted in 38 patients, and a family history of mesothelioma was observed in 2 patients. Common symptoms at the time of consultation included dyspnea in 26 cases, chest pain in 10 cases, and cough in 9 cases. Thoracentesis was followed by thoracoscopic pleural biopsy under general anesthesia in all 50 patients. No adverse events related to thoracentesis were observed in any of the cases. However, adverse events associated with pleural biopsy were noted in 7 cases,
Outcome measures
the specificity of this test was 100%
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
To compare between result of pleural effusion examination and result of pleural biopsy
Management information
Registered date
| 2019 | Year | 11 | Month | 28 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044132
