UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of duodenal juice Analysis of the markers in the duodenal juice to detect early stage pancreatic cancer
Title of the study (Brief title)	Analysis of the markers in the duodenal juice to detect early stage pancreatic cancer
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to assess the utility of markers in the duodenal juice obtained without pancreatic duct cannulation to detect pancreatic cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The protein levels in the duodenal juice to detect patients with stage 0/1 pancreatic cancer
Key secondary outcomes	The protein levels in the duodenal juice to detect pancreatic cancer and its sensitivity, The protein levels in the duodenal juice to detect pancreatic diseases

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	Prevention
Type of intervention	Device,equipment Maneuver Other
Interventions/Control_1	At the beginning of the endoscopy, the duodenum is entered within a few minutes and we collect the duodenal juice. The collection of duodenal juice The duodenal juice is collected using PR-130Q catheter and 20ml-syringe. The catheter is removed when the sample reaches more than 0.3ml or the procedure takes more than 5 minutes. The sample is immediately put into 2ml-tube with a protease inhibitor (Roche) and stored at -80degrees.
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1st stage: 1) Aged 50 or more 2) Patients who undergo preoperative screening upper gastrointestinal endoscopy or endoscopic ultrasonography (EUS) for the assessment of pancreatic cancer 3) Written informed consent 4) Patients without definite malignant diseases in upper gastrointestinal lesion except pancreatic cancer 5) Patients who have undergone no surgery in gastrointestinal lesion 6) Patients without malignant disease in bile duct 2nd stage: 1) Aged 50 or more 2) Patients who undergo screening upper gastrointestinal endoscopy or EUS for their pancreatic diseases. 3) The written informed consent is obtained from all the participants in this study. 4) Patients without definite malignant diseases in upper gastrointestinal lesion except pancreatic cancer 5) Patients who have undergone no surgery in gastrointestinal lesion 7) Patients without malignant disease in bile duct Control: The renal transplantation donors 1) Aged 50 or more. 2) Patients proven to have normal pancreas by CT 3) Patients who undergo screening upper gastrointestinal endoscopy for their pancreatic diseases 4) Written informed consent 5) Patients without definite malignant diseases in upper gastrointestinal lesion except pancreatic cancer 6) Patients who have undergone no surgery in gastrointestinal lesion, such as gastrectomy, pancreatoduodenectomy and so on. 7) Patients without malignant disease in bile duct The patients who undergo physical examination 1) Aged 50 or more. 2) Patients proven to have normal pancreas by EUS 3) Patients who undergo screening upper gastrointestinal endoscopy for their pancreatic diseases 4) Written informed consent 5) Patients without definite malignant diseases in upper gastrointestinal lesion except pancreatic cancer 6) Patients who have undergone no surgery in gastrointestinal lesion, such as gastrectomy, pancreatoduodenectomy and so on. 7) Patients without malignant disease in bile duct
Key exclusion criteria	1) They have no drug hypersensitivity. 2) The doctor-in-charge figures them to be suitable for this study.
Target sample size	1200

Research contact person
Name of lead principal investigator	Masao Tanaka
Organization	Shimonoseki City Hospital Graduate School of Medical Sciences, Kyushu University
Division name	ditector
Address	1-13-1 Koyocho, Shimonoseki, Yamaguchi, 750-8520, Japan
TEL	092-631-2920
Email	dj@cres-kyushu.or.jp

Public contact
Name of contact person	Takao Ohtsuka
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Department of Surgery and Oncology
Address	3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
TEL	092-631-2920
Homepage URL
Email	dj@cres-kyushu.or.jp

Sponsor
Institute	Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization	Olympus Corp
Organization
Division
Category of Funding Organization	Profit organization
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	九州大学 JA尾道総合病院 手稲渓仁会病院 愛知県がんセンター中央病院 千葉県がんセンター 近畿大学 山梨大学 山梨県厚生連健康管理センター 戸畑共立病院 福岡赤十字病院

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 05 Month 22 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	2014 Year 12 Month 03 Day
Last modified on	2018 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018045