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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019259
Receipt No. R000022102
Scientific Title Molecular biological analysis of the factors involved in the diagnosis, therapeutic effect prediction and prognosis of biliary tract and pancreatic tumor
Date of disclosure of the study information 2015/10/10
Last modified on 2015/10/07

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Basic information
Public title Molecular biological analysis of the factors involved in the diagnosis, therapeutic effect prediction and prognosis of biliary tract and pancreatic tumor
Acronym Molecular biological analysis of biliary tract and pancreatic tumor
Scientific Title Molecular biological analysis of the factors involved in the diagnosis, therapeutic effect prediction and prognosis of biliary tract and pancreatic tumor
Scientific Title:Acronym Molecular biological analysis of biliary tract and pancreatic tumor
Region
Japan

Condition
Condition biliary tract and pancreatic tumor
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To develop new methods of diagnosis, chemosensitivity prediction, and prognosis prediction of biliary tract and pancreatic tumor by analyzing molecular biological factors using surgical specimens, EUS-FNA samples,and peripheral blood samples.
Basic objectives2 Others
Basic objectives -Others To develop new methods of diagnosis, chemosensitivity prediction, and prognosis prediction
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic method: the relationship between the analyzing factors and pathological diagnosis
Chemosensitivity: the relationship between the analyzing factors and the chemosensitivity evaluated by RECIST guidelines version 1.1
Prognosis: the relationship between the analyzing factors and overall survival
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
Maneuver
Interventions/Control_1 Blood collection of peripheral blood
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 Biliary tract and pancreatic tumor patients, biliary tract and pancreatic inflammatory disease patients, multiple sclerosis patients, and healthy volunteers.
Following conditions are needed for inclusion;
(1) more than 20 years old.
(2) the consent of participation in this study is obtained as a writing document from participant or the family.
Key exclusion criteria Patients who are clearly expected to develop fatal complications by blood sampling.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kensuke Kubota
Organization Yokohama City University Graduate School of Medicine
Division name Department of Oncology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL +81-45-787-2640
Email kubotak@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Kato
Organization Yokohma City University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL +81-45-787-2640
Homepage URL
Email shin800m@yokohama-cu.ac.jp

Sponsor
Institute Yokohma City University Hospital
Institute
Department

Funding Source
Organization The Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 10 Month 10 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 Enrolling by invitation
Date of protocol fixation
2015 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 13 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
2015 Year 10 Month 07 Day
Last modified on
2015 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022102

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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