UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008737 |
|---|---|
| Receipt number | R000010250 |
| Scientific Title | An immunohistochemical analysis of epithelial-to-mesenchymal transition associating molecules for the patients of pulmonary sarcomatoid carcinoma. |
| Date of disclosure of the study information | 2012/08/22 |
| Last modified on | 2017/05/14 10:57:40 |
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Basic information
Public title
An immunohistochemical analysis of epithelial-to-mesenchymal transition associating molecules for the patients of pulmonary sarcomatoid carcinoma.
Acronym
An immunohistochemical analysis of epithelial to mesenchymal transition associating molecules for the patients of pulmonary sarcomatoid carcinoma.
Scientific Title
An immunohistochemical analysis of epithelial-to-mesenchymal transition associating molecules for the patients of pulmonary sarcomatoid carcinoma.
Scientific Title:Acronym
An immunohistochemical analysis of epithelial to mesenchymal transition associating molecules for the patients of pulmonary sarcomatoid carcinoma.
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the biological status of epithelial-to-mesenchymal transition between patients of pulmonary sarcomatoid carcinoma and adenocarcinoma.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The level of expression and phosphorylation of epithelial-to-mesenchymal transition associating molecules.
Key secondary outcomes
Overall survival, Progression-free survival, Tumor responses of treatment.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Form December 2006 to December 2010, histologically diagnosed pulmonary sarcomatoid carcinoma and adenocarcinoma in Kansai Medical University Takii Hospital and Hirakata Hospital, Japan.
Key exclusion criteria
(1)Patient who lacked adequate amount of histological specimen.
(2)Patient who refused to participate of this study.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Tamaki |
Organization
Kansai Medical University
Division name
First department of internal medicine
Zip code
Address
Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL
06-6992-1001
tamakit@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Tamaki |
Organization
Kansai Medical University
Division name
First department of internal medicine
Zip code
Address
Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL
06-6992-1001
Homepage URL
tamakit@hirakata.kmu.ac.jp
Sponsor or person
Institute
First department of internal medicine, Kansai Medical University.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
関西医科大学（大阪府）/Kansai Medical University, Osaka
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.spandidos-publications.com/10.3892/ol.2017.5864
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 | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 21 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 05 | Month | 31 | Day |
Other
Other related information
Clinico-pathological information is retrospectively collected. We examine the expressions of epithelial-to-mesenchymal transition associated molecules using immunohistochemistry, and compare clinico-pathological features between the patients with pulmonary sarcomatoid carcinoma and adenocarcinoma.
Management information
Registered date
| 2012 | Year | 08 | Month | 20 | Day |
Last modified on
| 2017 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010250
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
