UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prognostic impact of inflammatory-related biomarkers on the overall survival of patients with non-operable malignant pleural mesothelioma
Title of the study (Brief title)	Prognostic impact of inflammatory-related biomarkers on the overall survival of patients with non-operable malignant pleural mesothelioma
Region	Japan

Condition
Condition	malignant pleural mesothelioma
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We aimed to assess the prognostic utilities of inflammatory-related biomarkers in non-operable MPM patients.
Basic objectives2	Others
Basic objectives -Others	none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	overall survival
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	15 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	The medical records of consecutive patients with histologically confirmed malignant pleural mesothelioma (MPM) between January 2007 and August 2017 in our hospital were reviewed retrospectively.
Key exclusion criteria	MPM patients who received surgical treatment were excluded from this study. Patients who had active inflammatory disease (such as rheumatoid arthritis) or infection at the time of MPM diagnosis were excluded. Patients who were treated by chemotherapy or radiotherapy before the histological diagnosis of MPM, patients with MPM confirmed by autopsy, patients who had entered clinical trial study, patients with insufficient follow-up period (patients with follow-up period of less than one month after the diagnosis of MPM or patients who had received treatment at other hospitals after the diagnosis of MPM), were also excluded.
Target sample size	140

Research contact person
Name of lead principal investigator	Takehiro Otoshi
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of Respiratory Medicine
Address	2-17-77 Higashinaniwa-cho, Amagasaki, Hyogo 660-8550, Japan
TEL	+81-(0)6-6480-7000
Email	takehiro-otoshi19850902@gmail.com

Public contact
Name of contact person	Takehiro Otoshi
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of Respiratory Medicine
Address	2-17-77 Higashinaniwa-cho, Amagasaki, Hyogo 660-8550, Japan
TEL	+81-(0)6-6480-7000
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	2017 Year 12 Month 07 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 11 Month 17 Day
Anticipated trial start date	2017 Year 11 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	A retrospective observational study in a single center

Management information
Registered date	2017 Year 12 Month 06 Day
Last modified on	2017 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034584