UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010287
Receipt number R000012045
Scientific Title Prognostic impact of platelet indices for advanced non-small cell lung cancer: A retrospective analysis.
Date of disclosure of the study information 2013/03/22
Last modified on 2014/03/22 11:45:27

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Basic information

Public title

Prognostic impact of platelet indices for advanced non-small cell lung cancer: A retrospective analysis.

Acronym

Platelet indices in NSCLC.

Scientific Title

Prognostic impact of platelet indices for advanced non-small cell lung cancer: A retrospective analysis.

Scientific Title:Acronym

Platelet indices in NSCLC.

Region

Japan


Condition

Condition

advanced non small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of platelet indices as predictive factors for OS of non small cell lung cancer.

Basic objectives2

Others

Basic objectives -Others

Overall survival time

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Contribution of platelet indices for survival.

Key secondary outcomes

Characteristics of platelet indices in non small cell lung cancer.


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

Histologicaly or cytologicaly diagnosed NSCLC.
Stage IIIb or IV at initial diagnosis.
Patients of NSCLC who received medical examination and treatment at Kansai Medical University Takii Hospital from January 2002 to December 2012.

Key exclusion criteria

Patients who lack adequate medical record.
Patients who received thoracic irradiation with curative intention.
Patients who were diagnosed as LC-NEC.

Target sample size

268


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiki Shimizu

Organization

Kansai Medical University

Division name

1st department of internal medicine

Zip code


Address

Fumizono-cho 10-15, Moriguchi-city, Osaka.

TEL

06-6992-1001

Email

shimizto@takii.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiki Shimizu

Organization

Kansai Medical University

Division name

1st department of internal medicine

Zip code


Address

Fumizono-cho 10-15, Moriguchi-city, Osaka.

TEL

06-6992-1001

Homepage URL


Email

shimizto@takii.kmu.ac.jp


Sponsor or person

Institute

Kansai Medical University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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



Other administrative information

Date of disclosure of the study information

2013 Year 03 Month 22 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.sciencedirect.com/science/article/pii/S0169500213003851?via=ihub

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

Completed

Date of protocol fixation

2013 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 04 Month 01 Day

Last follow-up date

2013 Year 05 Month 31 Day

Date of closure to data entry

2013 Year 06 Month 01 Day

Date trial data considered complete

2013 Year 06 Month 01 Day

Date analysis concluded

2013 Year 06 Month 30 Day


Other

Other related information

To evaluate the survival impact of platelet indices in advanced non small cell lung cancer.


Management information

Registered date

2013 Year 03 Month 21 Day

Last modified on

2014 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012045


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name