UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An immunohistochemical analysis of epithelial-to-mesenchymal transition associating molecules for the patients of pulmonary sarcomatoid carcinoma.
Title of the study (Brief title)	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	Takeshi Tamaki
Organization	Kansai Medical University
Division name	First department of internal medicine
Address	Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL	06-6992-1001
Email	tamakit@takii.kmu.ac.jp

Public contact
Name of contact person	Takeshi Tamaki
Organization	Kansai Medical University
Division name	First department of internal medicine
Address	Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL	06-6992-1001
Homepage URL
Email	tamakit@hirakata.kmu.ac.jp

Sponsor
Institute	First department of internal medicine, Kansai Medical University.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.spandidos-publications.com/10.3892/ol.2017.5864
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010250