UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009041 |
|---|---|
| Receipt number | R000010145 |
| Scientific Title | DNA and RNA analyses in bile and pancreatic juice by the next-generation sequencer |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2016/02/20 14:27:27 |
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Basic information
Public title
DNA and RNA analyses in bile and pancreatic juice by the next-generation sequencer
Acronym
Pathogenetic factor analyses in bile and pancreatic juice
Scientific Title
DNA and RNA analyses in bile and pancreatic juice by the next-generation sequencer
Scientific Title:Acronym
Pathogenetic factor analyses in bile and pancreatic juice
Region
| Japan |
Condition
Condition
Pancreato-biliary diseases
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate novel biomarkers for the early detection of pancreatic cancer or bile duct cancer
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The presence or absence of pancreato-biliary malignancies
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Among patients who will be performed ERCP in Keio University Hospital, those whom pancreatic or bile juice will to be aspirated at ERCP for cytological diagnosis are included.
Key exclusion criteria
Patients whom pancreatic or bile juice could not be obtained, and who could not be diagnosed whether their diseases were benign or malignancy are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidekazu Suzuki |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
TEL
03-5363-3914
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidekazu Suzuki |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
TEL
03-5363-3914
Homepage URL
http://www.keio-med.jp/gastro/ugt/index.html
hsuzuki@a6.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
Management information
Registered date
| 2012 | Year | 10 | Month | 04 | Day |
Last modified on
| 2016 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010145
