UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015832 |
|---|---|
| Receipt number | R000018045 |
| Scientific Title | Study of duodenal juice Analysis of the markers in the duodenal juice to detect early stage pancreatic cancer |
| Date of disclosure of the study information | 2014/12/05 |
| Last modified on | 2018/10/01 13:17:01 |
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Basic information
Public title
Study of duodenal juice
Analysis of the markers in the duodenal juice to detect early stage pancreatic cancer
Acronym
Analysis of the markers in the duodenal juice to detect early stage pancreatic cancer
Scientific Title
Study of duodenal juice
Analysis of the markers in the duodenal juice to detect early stage pancreatic cancer
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masao Tanaka |
Organization
Shimonoseki City Hospital
Graduate School of Medical Sciences, Kyushu University
Division name
ditector
Zip code
Address
1-13-1 Koyocho, Shimonoseki, Yamaguchi, 750-8520, Japan
TEL
092-631-2920
dj@cres-kyushu.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takao Ohtsuka |
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
092-631-2920
Homepage URL
dj@cres-kyushu.or.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018045
