UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018143
Receipt number 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 09:09:37

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Hyogo Prefectural Amagasaki General Medical Center

Institute

Department

Personal name



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

Value
https://center6.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