UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007414
Receipt number R000008736
Scientific Title Retrospective study of the relationship between histopathological features based on new proposed classification (IASLC/ATS/ERS classification) of lung adenocarcinoma and somatic mutation
Date of disclosure of the study information 2012/03/01
Last modified on 2014/09/09 10:04:05

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Basic information

Public title

Retrospective study of the relationship between histopathological features based on new proposed classification (IASLC/ATS/ERS classification) of lung adenocarcinoma and somatic mutation

Acronym

Retrospective study of the relationship between histopathological features based on new proposed classification of lung adenocarcinoma and somatic mutation

Scientific Title

Retrospective study of the relationship between histopathological features based on new proposed classification (IASLC/ATS/ERS classification) of lung adenocarcinoma and somatic mutation

Scientific Title:Acronym

Retrospective study of the relationship between histopathological features based on new proposed classification of lung adenocarcinoma and somatic mutation

Region

Japan


Condition

Condition

Lung carcinoma

Classification by specialty

Pneumology Chest surgery Laboratory medicine

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To examine the frequency of new subtype of lung adenocarcinoma and the relationship between the pathological features and somatic mutations

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Frequency of histological type

Key secondary outcomes

Relationship between each histological type and age at operation, sex, tumor size and EGFR gene mutation


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

Cases without preoperative treatment
Submission of all the HE sections of the largest cross-sectional slice is capable.
Cases diagnosed as adenocarcinoma in the pathological report

Key exclusion criteria

Cases diagnosed as metastatic lung carcinoma, combined small cell carcinoma, combined large cell neuroendocrine carcinoma
Cases with preoperative treatment
Recurrent cases
Rejected cases to use clinical data
Cases determined as inappropriate to include this research by the principal investigator

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukito Ichinose

Organization

NHO Kyushu Cancer Center

Division name

Institute for Clinical Research

Zip code


Address

3-1-1 Notame, Minami-ku, Fukuoka

TEL

092-541-3231

Email

yichinos@nk-cc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenichi Taguchi

Organization

NHO Kyushu Cancer Center

Division name

Department of Clinical Laboratory Medicine/Pathology, Clinical Division

Zip code


Address

3-1-1 Notame, Minami-ku, Fukuoka

TEL

092-541-3231

Homepage URL

http://www.ia-nkcc.jp/

Email

kentag@nk-cc.go.jp


Sponsor or person

Institute

Lung Oncology Group in Kyushu, Japan (LOGIK)

Institute

Department

Personal name



Funding Source

Organization

Clinical Research Support Center Kyushu

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

JAPAN


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

2012 Year 03 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

2011 Year 10 Month 08 Day

Date of IRB


Anticipated trial start date

2012 Year 01 Month 01 Day

Last follow-up date

2013 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To examine the frequency of new subtype of lung adenocarcinoma and the relationship between the pathological features and somatic mutations


Management information

Registered date

2012 Year 03 Month 01 Day

Last modified on

2014 Year 09 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008736


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name