UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research of gemcitabine sensitivity in pancreatic cancer.
Title of the study (Brief title)	Research of gemcitabine sensitivity in pancreatic cancer.
Region	Japan

Condition
Condition	Advanced pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will observe the relationship between the level of phosphorylated heat shock protein 27 (HSP27) obtained from human pancreatic cancer by EUS-FNA and the sensitivity to gemcitabine (GEM) in order to find god prognostic marker.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate and prognosis of chmotherapy with GEM.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Chemotherapy including gemcitabine.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Advanced pancreatic cancer diagnosed by EUS-FNA.
Key exclusion criteria	Advanced pancreatic cancer could not be diagnosed by EUS-FNA.
Target sample size	100

Research contact person
Name of lead principal investigator	Ichiro Yasuda
Organization	Gifu University
Division name	Dept. of Gastroenterology
Address	1-1 Yanagido, Gifu 501-1194, Japan
TEL	058-230-6308
Email	yasudaic@gmail.com

Public contact
Name of contact person	Ichiro Yasuda
Organization	Gifu University
Division name	Dept. of Gastroenterology
Address	1-1 Yanagido, Gifu 501-1194, Japan
TEL	058-230-6308
Homepage URL
Email	yasudaich@gmail.com

Sponsor
Institute	Gifu University Dept. of Gastroenterology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology of Japan.
Organization
Division
Category of Funding Organization	Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 03 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 12 Month 05 Day
Last modified on	2016 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008075