UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024354 |
|---|---|
| Receipt number | R000028041 |
| Scientific Title | Diagnostic accuracy of soluble mesothelin-related peptide in undiagnosed pleural effusions: a retrospective study in a single center |
| Date of disclosure of the study information | 2016/10/12 |
| Last modified on | 2017/10/21 17:09:55 |
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Basic information
Public title
Diagnostic accuracy of soluble mesothelin-related peptide in undiagnosed pleural effusions: a retrospective study in a single center
Acronym
Diagnostic accuracy of soluble mesothelin-related peptide in undiagnosed pleural effusions: a retrospective study in a single center
Scientific Title
Diagnostic accuracy of soluble mesothelin-related peptide in undiagnosed pleural effusions: a retrospective study in a single center
Scientific Title:Acronym
Diagnostic accuracy of soluble mesothelin-related peptide in undiagnosed pleural effusions: a retrospective study in a single center
Region
| Japan |
Condition
Condition
malignant pleural mesothelioma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the diagnostic accuracy of soluble mesothelin-related peptide in undiagnosed pleural effusions.
Basic objectives2
Others
Basic objectives -Others
To examine the diagnostic accuracy of CEA, CYFRA21-1 and CT findings in undiagnosed pleural effusions.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of soluble mesothelin-related peptide in pleural effusions
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with pleural effusions
Key exclusion criteria
Patients with pretreated malignant pleural disease
Patients with proven diagnosis of pleural effusion
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Otoshi Takehiro |
Organization
Hyogo prefectural amagasaki general medical center
Division name
pulmonary medicine
Zip code
Address
2-17-77, Higashinanba-cho, Amagasaki-city, Hyogo
TEL
06-6480-7000
takehiro.otoshi19850902@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Otoshi Takehiro |
Organization
Hyogo prefectural amagasaki general medical center
Division name
pulmonary medicine
Zip code
Address
2-17-77, Higashinanba-cho, Amagasaki-city, Hyogo
TEL
06-6480-7000
Homepage URL
takehiro.otoshi19850902@gmail.com
Sponsor or person
Institute
Hyogo prefectural amagasaki general medical center
Institute
Department
Personal name
Funding Source
Organization
Hyogo prefectural amagasaki general medical center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 10 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0185850
Number of participants that the trial has enrolled
Results
In this study, we aimed to examine the clinical value of the pleural effusion (PE) biomarkers, soluble mesothelin-related peptide (SMRP), cytokeratin 19 fragment (CYFRA 21-1) and carcinoembryonic antigen (CEA), and the utility of combining chest computed tomography (CT) findings with these biomarkers, in diagnosing malignant pleural mesothelioma (MPM). We conducted a retrospective cohort study in a single center. Consecutive patients with undiagnosed pleural effusions who underwent PE analysis between September 2014 and August 2016 were reviewed. This study included 240 patients (32 with MPM and 208 non-MPM). SMRP and the CYFRA 21-1/CEA ratio had a sensitivity and specificity for diagnosing MPM of 56.3% and 86.5%, and 87.5% and 74.0%, respectively. Using receiver operating characteristics (ROC) curve analysis of the ability of these markers to distinguish MPM from all other PE causes, the area under the ROC curve (AUC) for SMRP and the CYFRA 21-1/CEA ratio was 0.804 and 0.874, respectively. The sensitivity and specificity of SMRP combined with the CYFRA 21-1/CEA ratio were 93.8% and 64.9%, respectively. The sensitivity of the combination of SMRP, the CYFRA 21-1/CEA ratio, and the presence of Leung's criteria (a chest CT finding that is suggestive of malignant pleural disease) was 93.8%. In conclusion, the combined PE biomarkers had a high sensitivity for diagnosing MPM, although the addition of chest CT findings did not improve the sensitivity of SMRP combined with the CYFRA 21-1/CEA ratio. Combination of these biomarkers helped to rule out MPM effectively among patients at high risk of suffering MPM and would be valuable especially for old frail patients who have difficulty in undergoing invasive procedures such as thoracoscopy.
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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 08 | Month | 27 | Day |
Other
Other related information
retrospective study
Management information
Registered date
| 2016 | Year | 10 | Month | 11 | Day |
Last modified on
| 2017 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028041
