UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007294 |
|---|---|
| Receipt number | R000008566 |
| Scientific Title | The analysis of significance of EGFR mutations in lung non-adeno and non small cell carcinoma; retrospective multicenter study |
| Date of disclosure of the study information | 2012/02/15 |
| Last modified on | 2014/03/17 09:59:08 |
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Basic information
Public title
The analysis of significance of EGFR mutations in lung non-adeno and non small cell carcinoma; retrospective multicenter study
Acronym
The analysis of significance of EGFR mutations in lung non-adeno and non small cell carcinoma; retrospective multicenter study
Scientific Title
The analysis of significance of EGFR mutations in lung non-adeno and non small cell carcinoma; retrospective multicenter study
Scientific Title:Acronym
The analysis of significance of EGFR mutations in lung non-adeno and non small cell carcinoma; retrospective multicenter study
Region
| Japan |
Condition
Condition
EGFR mutations in lung non-adeno and non small cell carcinoma
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
In this study, we retrospectively assessed the mutation of EGFR and efficacy of EGFR-TKI.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effectiveness of EGFR-TKI in non-adeno and non-small cell lung cancer
Key secondary outcomes
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
The cases of non-adeno and non-small cell lung cancer with EGFR-TKI treatment
Key exclusion criteria
The case that refused research participation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Sugio |
Organization
Oita University Faculty of Medicine
Division name
Department of Thoracic and Breast Surgery
Zip code
Address
1-1, Idaigaoka, Hazamatyou , Yufu-shi,Oita, Japan
TEL
097-549-4411
sugio.k@nk-cc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Ohba |
Organization
National Kyushu Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
3-1-1, Notame, Minamiku, Fukuoka. 811-1395, Japan
TEL
092-541-3231
Homepage URL
ooba.t@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 | 02 | Month | 15 | 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
| 2011 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we retrospectively assessed the mutation of EGFR and efficacy of EGFR-TKI.
Management information
Registered date
| 2012 | Year | 02 | Month | 15 | Day |
Last modified on
| 2014 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008566
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
