UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005701
Receipt number R000006744
Scientific Title Prospective cohort study in patients with lung cancer, pleural mesothelioma, and breast cancer
Date of disclosure of the study information 2011/06/01
Last modified on 2013/09/29 09:40:10

* 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

Prospective cohort study in patients with lung cancer, pleural mesothelioma, and breast cancer

Acronym

Prospective cohort study in patients with lung cancer, pleural mesothelioma, and breast cancer

Scientific Title

Prospective cohort study in patients with lung cancer, pleural mesothelioma, and breast cancer

Scientific Title:Acronym

Prospective cohort study in patients with lung cancer, pleural mesothelioma, and breast cancer

Region

Japan


Condition

Condition

lung cancer, pleural mesothelioma, and breast cancer

Classification by specialty

Chest surgery Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to investigate clical factors for
survival.

Basic objectives2

Others

Basic objectives -Others

Observation study

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Primary endpoint: OS

Key secondary outcomes

Secondary endpoint: clinical factors regarding survival


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 were eligible for informed consent.

Key exclusion criteria

none

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fumihiro Tanaka

Organization

University of Occupational and Environmental Health

Division name

Second Department of Surgery

Zip code


Address

1-1 Iseigaoka, Yahatanishi-ku

TEL

0936917442

Email

ftanaka@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name HIDETAKA URAMOTO

Organization

University of Occupational and Environmental Health

Division name

Second Department of Surgery

Zip code


Address

1-1 Iseigaoka, Yahatanishi-ku

TEL

0936917442

Homepage URL


Email

hidetaka@med.uoeh-u.ac.jp


Sponsor or person

Institute

University of Occupational and Environmental Health

Institute

Department

Personal name



Funding Source

Organization

University of Occupational and Environmental Health

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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

産業医科大学病院


Other administrative information

Date of disclosure of the study information

2011 Year 06 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

Terminated

Date of protocol fixation

2011 Year 01 Month 12 Day

Date of IRB


Anticipated trial start date

2011 Year 06 Month 01 Day

Last follow-up date

2013 Year 09 Month 14 Day

Date of closure to data entry

2013 Year 09 Month 14 Day

Date trial data considered complete

2013 Year 09 Month 14 Day

Date analysis concluded

2013 Year 09 Month 14 Day


Other

Other related information

To investigate the clinical factors for survival


Management information

Registered date

2011 Year 06 Month 01 Day

Last modified on

2013 Year 09 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006744


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name