UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011018
Receipt number R000012900
Scientific Title Prognostic impact of MPV for non–squamous non–small cell lung cancer patients who received front line chemotherapy in combination with bevacizumab: A retrospective analysis.
Date of disclosure of the study information 2013/06/24
Last modified on 2021/07/02 09:57:52

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Basic information

Public title

Prognostic impact of MPV for non–squamous non–small cell lung cancer patients who received front line chemotherapy in combination with bevacizumab: A retrospective analysis.

Acronym

MPV and Bevacitumab in NSCLC.

Scientific Title

Prognostic impact of MPV for non–squamous non–small cell lung cancer patients who received front line chemotherapy in combination with bevacizumab: A retrospective analysis.

Scientific Title:Acronym

MPV and Bevacitumab in NSCLC.

Region

Japan


Condition

Condition

non–squamous 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 Biological effects of Bevacizumab to MPV.

Basic objectives2

Others

Basic objectives -Others

Survival impact of MPV

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Biological effects of bevacizumab to MPV.

Key secondary outcomes

Contribution of MPV for survival of NSCLC patients who received chemotherapy in combination with Bevacizumab.


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Histologicaly or cytologicaly diagnosed non-squamous NSCLC.
Stage IV (7th edition) at initial diagnosis.
Patients of non squamous NSCLC who received front line chemotherapy at Hirakata or Kansai Medical University Takii Hospital from November 2009 to April 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

250


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shosaku Nomura

Organization

Kansai Medical University

Division name

1st department of internal medicine

Zip code


Address

Shin-machi 2-3-1, Hirakata-city, Osaka.

TEL

072-804-0101

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shosaku Nomura

Organization

Kansai Medical University

Division name

1st department of internal medicine

Zip code


Address

Shin-machi 2-3-1, Hirakata-city, Osaka.

TEL

072-804-0101

Homepage URL


Email

nomurash@hirakata.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

関西医科大学附属枚方病院(大阪府)Kansai Medical University Hirakata Hospital (Osaka)


Other administrative information

Date of disclosure of the study information

2013 Year 06 Month 24 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

Completed

Date of protocol fixation

2013 Year 04 Month 01 Day

Date of IRB

2013 Year 06 Month 19 Day

Anticipated trial start date

2013 Year 05 Month 01 Day

Last follow-up date

2013 Year 07 Month 01 Day

Date of closure to data entry

2013 Year 07 Month 01 Day

Date trial data considered complete

2013 Year 07 Month 01 Day

Date analysis concluded

2013 Year 08 Month 01 Day


Other

Other related information

To evaluate the efficacy of MPV as a predictive factor for OS of NSCLC patients who received front line chemotherapy in combination with Bevacizumab.


Management information

Registered date

2013 Year 06 Month 22 Day

Last modified on

2021 Year 07 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012900


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name