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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018143
Receipt No. R000020828
Scientific Title Prognostic index for overall survival in malignant mesothelioma: external validation.
Date of disclosure of the study information 2015/08/01
Last modified on 2016/12/31

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Basic information
Public title Prognostic index for overall survival in malignant mesothelioma: external validation.
Acronym Prognostic index for overall survival in malignant mesothelioma: external validation.
Scientific Title Prognostic index for overall survival in malignant mesothelioma: external validation.
Scientific Title:Acronym Prognostic index for overall survival in malignant mesothelioma: external validation.
Region
Japan

Condition
Condition malignant pleural mesothelioma
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The study aim is to conduct external validation for the prognostic index for the malignant pleural mesothelioma
Basic objectives2 Others
Basic objectives -Others To conduct external validation for the prognostic index for the malignant pleural mesothelioma
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients pathologically confirmed with maliganant pleural mesothelioma in Hyogo Prefectural Amagasaki Hospital or Hyogo College of Medicine Hospital between 4/2007 to 3/2015
Key exclusion criteria Double cancer patients.
Treated by chemotherapy, radiotherapy
before diagnosis.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KATAOKA Yuki
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Department of Respiratory Medicine, Hospital Care Research Unit
Zip code
Address Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo 660-0892, Japan.
TEL 06-6480-7000
Email hanshin.crt@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name KATAOKA Yuki
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Department of Respiratory Medicine, Hospital Care Research Unit
Zip code
Address Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo 660-0892, Japan.
TEL 06-6480-7000
Homepage URL
Email hanshin.crt@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 Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Hyogo College of Medicine Hospital
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
2015 Year 08 Month 01 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 No longer recruiting
Date of protocol fixation
2015 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Data extracted from charts are age, gender, ECOG PS, smoking history, asbest exposure, comorbidities, histological types, cTNM, stage(IMIG), treatment modality

Management information
Registered date
2015 Year 07 Month 01 Day
Last modified on
2016 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020828

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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