UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020641 |
|---|---|
| Receipt number | 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 22:28:18 |
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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
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
mtaketo@surg1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023825
