UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective cohort study on patients of pancreatic cancer performed EUSFNA
Title of the study (Brief title)	Prospective cohort study on patients of pancreatic cancer performed EUSFNA
Region	Japan

Condition
Condition	Pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To find the relation between molecular characteristics of pancreatic cancer and the efficacy of anticancer drugs
Basic objectives2	Others
Basic objectives -Others	To find the relation between molecular characteristics of pancreatic cancer and metabolic substances of pancreatic cancer
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	No Primary outcome.Because this study aimed at the accumulation of data and FNA specimen.
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	To be able to give informed consent
Key exclusion criteria	None
Target sample size	1000

Research contact person
Name of lead principal investigator	Atsuhiro Masuda
Organization	Kobe University Hospital
Division name	Dep. of Gastroenterology
Address	7-5-1 Kusunoki-cho Chuo-ku Kobe
TEL	078-382-6305
Email	atmasuda@med.kobe-u.ac.jp

Public contact
Name of contact person	Atsuhiro Masuda
Organization	Kobe University Hospital
Division name	Dep. of Gastroenterology
Address	7-5-1 Kusunoki-cho Chuo-ku Kobe
TEL	078-382-6305
Homepage URL
Email	atmasuda@med.kobe-u.ac.jp

Sponsor
Institute	Division of Gastroenterology, Department of Internal medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Division of Gastroenterology, Department of Internal medicine, Kobe University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 22 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 01 Day
Anticipated trial start date	2016 Year 11 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	Unpublished
URL releasing results
Results	The aim of this research is registry of pancreatic cancer performed EUSFNA. Therefore there is no main outcome. In each individual study, we will perform UMIN registration.
Other related information	We collected the information of patient's charactaristics, EUSFNA specimens, and serum.

Management information
Registered date	2017 Year 02 Month 22 Day
Last modified on	2018 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027885