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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020641
Receipt No. R000023825
Scientific Title A minimally invasive and simple screening test to detect pancreatic cancer using biomarkers in duodenal juice collected by a forward-view endoscope
Date of disclosure of the study information 2016/01/20
Last modified on 2016/01/19

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Basic information
Public title A minimally invasive and simple screening test to detect pancreatic cancer using biomarkers in duodenal juice collected by a forward-view endoscope
Acronym A minimally invasive and simple screening test to detect pancreatic cancer using biomarkers in duodenal juice collected by a forward-view endoscope
Scientific Title A minimally invasive and simple screening test to detect pancreatic cancer using biomarkers in duodenal juice collected by a forward-view endoscope
Scientific Title:Acronym A minimally invasive and simple screening test to detect pancreatic cancer using biomarkers in duodenal juice collected by a forward-view endoscope
Region
Japan

Condition
Condition Pancreatic diseases
Classification by specialty
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 protein marker levels of duodenal juice collected by a forward-view endoscope to detect pancreatic cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The protein levels in the duodenal juice to detect the patients with pancreatic cancer.
Key secondary outcomes The relationship between the protein markers and backgrounds of the patients.

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
Medicine Device,equipment Maneuver
Other
Interventions/Control_1 At the beginning of upper gastrointestinal endoscopy (GIE) or endoscopic ultrasonography (EUS), duodenal juice is collected near the duodenal papilla using PR-130Q catheter for 5 minutes. Duodenal juice is aspirated using two 20mL-syringes, one of which is added protease inhibitor. The sample is immediately put into a 2mL-tube and stored at -80 degrees celsius.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with pancreatic diseases
1) Aged 20 or more year-old
2) Patients who undergo screening upper gastrointestinal endoscopy (GIE) or endoscopic ultrasonography (EUS) for their pancreatic diseases
3) Written informed consent

Living renal transplantation donors
1) Aged 20 or more year-old
2) Living renal transplantation donors who undergo preoperative screening upper GIE
3) Written informed consent
Key exclusion criteria 1) Patients who have a history of severe complications due to endoscopy
2) Not written informed consent
3) Patients who the doctor-in-charge figures unsuitable for this study
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Tanaka
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Surgery and Oncology
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan
TEL 092-642-5441
Email masaotan@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taketo Matsunagato
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Surgery and Oncology
Zip code
Address 3-1-1, Maidashi, Higashi-Ku, Fukuoka, 812-8582, Japan
TEL 092-642-5441
Homepage URL
Email mtaketo@surg1.med.kyushu-u.ac.jp

Sponsor
Institute Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization Olympus corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT01699698
Org. issuing International ID_1 Clinical Trials. gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 九州大学病院 (福岡)、Mayo Clinic Jacksonville (Florida, USA)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Completed
Date of protocol fixation
2011 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 05 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 19 Day
Last modified on
2016 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023825

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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