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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030278
Receipt No. R000034584
Scientific Title Prognostic impact of inflammatory-related biomarkers on the overall survival of patients with non-operable malignant pleural mesothelioma
Date of disclosure of the study information 2017/12/07
Last modified on 2017/12/05

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Basic information
Public title Prognostic impact of inflammatory-related biomarkers on the overall
survival of patients with non-operable malignant pleural mesothelioma
Acronym Prognostic impact of inflammatory-related biomarkers on the overall
survival of patients with non-operable malignant pleural mesothelioma
Scientific Title Prognostic impact of inflammatory-related biomarkers on the overall
survival of patients with non-operable malignant pleural mesothelioma
Scientific Title:Acronym 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
1st name
Middle name
Last name Takehiro Otoshi
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Department of Respiratory Medicine
Zip code
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
1st name
Middle name
Last name Takehiro Otoshi
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Department of Respiratory Medicine
Zip code
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)

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
2017 Year 12 Month 07 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
2017 Year 11 Month 17 Day
Date of IRB
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

Other
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

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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