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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041292
Receipt No. R000047123
Scientific Title Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers
Date of disclosure of the study information 2020/08/03
Last modified on 2020/08/03

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Basic information
Public title Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers
Acronym Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers
Scientific Title Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers
Scientific Title:Acronym Analysis of S100 protein in the duodenal juice collected by oral endoscopy to detect early stage pancreatic cancers
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to assess the utility of S100 protein levels in the duodenal juice collected by oral endoscopy without pancreatic duct cannulation to detect pancreatic cancers.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The S100 protein concentration in the duodenal juice to detect patients with pancreatic cancers
Key secondary outcomes

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
Interventions/Control_1 At the beginning of the endoscopy, the duodenum is entered within a few minutes and we collect the duodenal juice. The duodenal juice is collected within 3 minutes. The sample is diluted 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 Pancreatic cancer patients
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

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 65

Research contact person
Name of lead principal investigator
1st name Nakamura
Middle name
Last name Masafumi
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Surgery and Oncology
Zip code 8128582
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
TEL 092-631-2920
Email mnaka@surg1.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Ideno
Middle name
Last name Noboru
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Surgery and Oncology
Zip code 8128582
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
TEL 092-642-5444
Homepage URL
Email ideno@surg1.med.kyushu-u.ac.jp

Sponsor
Institute Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyushu University certified institutional review board for clinical trials
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582 , Japan
Tel 0926425774
Email bynintei@jimu.kyushu-u.ac.jp

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
2020 Year 08 Month 03 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 65
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2020 Year 07 Month 15 Day
Date of IRB
2020 Year 07 Month 15 Day
Anticipated trial start date
2020 Year 07 Month 15 Day
Last follow-up date
2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 03 Day
Last modified on
2020 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047123

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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