UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Project for detection of pancreatic cancer at an early stage with curative surgery in Osaka city
Title of the study (Brief title)	Project for detection of pancreatic cancer at an early stage with curative surgery in Osaka city
Region	Japan

Condition
Condition	Pancreatic cancer at an early stage
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To improve the detection rate of pancreatic cancer at an early stage with curative surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Resection rate
Key secondary outcomes	Detection number of pancreatic cancer at an early stage

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Establish a social program for the early diagnosis of pancreatic cancer between practicing doctors and specialized doctors for pancreatic cancer in medical centers.
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	invasive ductal carcinoma of the pancreas
Key exclusion criteria	none
Target sample size	400

Research contact person
Name of lead principal investigator	Shujiro Yazumi
Organization	Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name	Digestive Disease Center
Address	2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN,530-8480
TEL	06-6312-1221
Email	s-yazumi@kitano-hp.or.jp

Public contact
Name of contact person	Yasushi Kudo
Organization	Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name	Digestive Disease Center
Address	2-4-20 Ohgimachi,Kita-ku,Osaka,JAPAN,530-8480
TEL	06-6312-1221
Homepage URL
Email	yoshiharu-mori@kitano-hp.or.jp

Sponsor
Institute	Tazuke Kofukai Medical Research Institute, Kitano Hospital
Institute
Department

Funding Source
Organization	Tazuke Kofukai Medical Research Institute, Kitano Hospital
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 04 Month 09 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 02 Month 01 Day
Anticipated trial start date	2014 Year 04 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
Other related information

Management information
Registered date	2017 Year 04 Month 09 Day
Last modified on	2018 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030563