UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004360 |
|---|---|
| Receipt number | R000005214 |
| Scientific Title | a study for association between environmental tobacco smoke exposure and EGFR and KRAS mutations in never smokers with non-small cell lung cancer |
| Date of disclosure of the study information | 2010/10/08 |
| Last modified on | 2016/04/13 12:42:59 |
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Basic information
Public title
a study for association between environmental tobacco smoke exposure and EGFR and KRAS mutations in never smokers with non-small cell lung cancer
Acronym
ETS and EGFR study
Scientific Title
a study for association between environmental tobacco smoke exposure and EGFR and KRAS mutations in never smokers with non-small cell lung cancer
Scientific Title:Acronym
ETS and EGFR study
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
to assess association between cumulative dose of ETS and development of EGFR and KRAS mutations
Basic objectives2
Others
Basic objectives -Others
molecular epidemiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
association between cumulative dose of ETS and development of EGFR and KRAS mutations
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
never smokers with NSCLC
Key exclusion criteria
nothing particulr
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoya Kawaguchi |
Organization
NHO Kinki-chuo Chest Medical Center
Division name
Internal Medicine
Zip code
Address
1180 Nagasone-cho, Sakai, Osaka591-8555, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
NHO Kinki-chuo Chest Medical Center
Division name
Internal Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
NHO Kinki-chuo Chest Medical Center
Institute
Department
Personal name
Funding Source
Organization
NHO Kinki-chuo Chest Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
| 2010 | Year | 10 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2008 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 13 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 13 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is to examine molecular markers in never-smokers with NSCLC
Management information
Registered date
| 2010 | Year | 10 | Month | 08 | Day |
Last modified on
| 2016 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005214
