UMIN-CTR Clinical Trial

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

Malignant pleural mesothelioma

Classification by specialty

Pneumology	Chest surgery	Laboratory medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hyogo Prefectural Amagasaki Hospital

Institute

Department

Personal name

Organization

no

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Hyogo College of Medicine Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

兵庫県立尼崎病院（兵庫県）
兵庫医科大学病院（兵庫県）

Date of disclosure of the study information

2014

Year

12

Month

10

Day

URL releasing protocol

http://www.amahosp.amagasaki.hyogo.jp/department/kokyu01/

Publication of results

Unpublished

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

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 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

Registered date

2014

Year

12

Month

02

Day

Last modified on

2019

Year

03

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018132