UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnostic accuracy of soluble mesothelin-related peptide in undiagnosed pleural effusions: a retrospective study in a single center
Title of the study (Brief title)	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	Otoshi Takehiro
Organization	Hyogo prefectural amagasaki general medical center
Division name	pulmonary medicine
Address	2-17-77, Higashinanba-cho, Amagasaki-city, Hyogo
TEL	06-6480-7000
Email	takehiro.otoshi19850902@gmail.com

Public contact
Name of contact person	Otoshi Takehiro
Organization	Hyogo prefectural amagasaki general medical center
Division name	pulmonary medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0185850
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.
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/icdr_e/ctr_view.cgi?recptno=R000028041