UMIN-CTR Clinical Trial

Basic information
Public title	Can Immunohistochemical markers be a prognostic factors in malignant pleural mesothelioma patients?
Acronym	Can Immunohistochemical markers be a prognostic factors in malignant pleural mesothelioma patients?
Scientific Title	Can Immunohistochemical markers be a prognostic factors in malignant pleural mesothelioma patients?
Scientific Title:Acronym	Can Immunohistochemical markers be a prognostic factors in malignant pleural mesothelioma patients?
Region	Japan

Condition
Condition	Malignant pleural mesothelioma
Classification by specialty	Pneumology Chest surgery Laboratory medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We evaluete the prognostic role of WT-1, Calretinin, and D2-40 expression in the patients with histologically proven epithelial or biphasic malignant pleural mesothelioma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcome endpoint will be overall survival, as defined by the length of time from the date of diagnosis to death. Patients who had not died or who were lost to follow-up were censored when they were last known to be alive before September 30, 2014.
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 definitive diagnosed with epithelial or biphasic mesothelioma from April 1, 2007 until September 30, 2014 in Hyogo Prefectural Amagasaki Hospital or Hyogo College of Medicine Hospital
Key exclusion criteria	Patients with simultaneous multiple cancer Patients diagnosed with tissue type other than a biphasic or epitherial mesotherioma Patients who had been diagnosed with autopsy
Target sample size	350

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Nobuko Maehashi
Organization	Hyogo Prefectural Amagasaki Hospital
Division name	Respiratory medicine
Zip code
Address	Amagasaki, Hyogo Prefecture Higashi-Daimotu-cho 1-1-1
TEL	06-6482-1521
Email	nobuko20051082@gmail.com

Public contact
1st name of contact person	1st name Middle name Last name Nobuko Maehashi
Organization	Hyogo Prefectural Amagasaki Hospital
Division name	Respiratory medicine
Zip code
Address	Amagasaki, Hyogo Prefecture Higashi-Daimotu-cho 1-1-1
TEL	06-6482-1521
Homepage URL	http://www.amahosp.amagasaki.hyogo.jp/department/kokyu01/
Email	nobuko20051082@gmail.com

Sponsor
Institute	Hyogo Prefectural Amagasaki Hospital
Institute
Department

Funding Source
Organization	no
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	兵庫県立尼崎病院（兵庫県） 兵庫医科大学病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 10 Day

Related information
URL releasing protocol	http://www.amahosp.amagasaki.hyogo.jp/department/kokyu01/
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	Terminated
Date of protocol fixation	2014 Year 10 Month 09 Day
Date of IRB	2014 Year 11 Month 30 Day
Anticipated trial start date	2014 Year 11 Month 30 Day
Last follow-up date	2019 Year 03 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

It is assumed that to extract the following data from the medical records. Both we use the ones that have been measured from 2 months before diagnosis after 1 month. If there is more than one process to use those closest to the date of diagnosis. Following factors will be extracted: age, gender, tissue type, symptoms (chest pain respiratory discomfort pleural effusion decreased appetite weight loss (half a year 5%)), Asbestos exposure history, Smoking history, comorbidities, ECOG PS, treatment including chemotherapy or surgery, blood and effusion parameters(Hb, Plt, WBC, WBC fraction, LDH, CEA, CYFRA, pleural WBC fractionated, total protein, LDH, sugar, CEA, and CYFRA), FDG-PET (To that effect in the case of information about cases that are not using the .FDG-PET there was a difference reviewed again by masking a result the image at the time of diagnosis to be performed in accordance with staging the TNM staging of IMIG will be recorded. surgery was performed cases to employ the pathological stage.) Immunostaining results: Calretinin, D2-40, , including the WT-1

Management information
Registered date	2014 Year 12 Month 02 Day
Last modified on	2019 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018132