UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prognostic index for overall survival in malignant mesothelioma: external validation.
Title of the study (Brief title)	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	KATAOKA Yuki
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of Respiratory Medicine, Hospital Care Research Unit
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	KATAOKA Yuki
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of Respiratory Medicine, Hospital Care Research Unit
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020828