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 | 2020/01/24 15:41:58 |
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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
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
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
Open public recruiting
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
| 2020 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044132
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
