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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024354
Receipt No. 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

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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
Email 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
Email takehiro.otoshi19850902@gmail.com

Sponsor
Institute Hyogo prefectural amagasaki general medical center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028041

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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