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
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/
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
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
