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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007414
Receipt No. 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

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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
Institute Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

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
URL(English) https://upload.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


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