UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019259 |
|---|---|
| Receipt number | 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 | 2022/02/23 14:46:26 |
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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
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
shin800m@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohma City University Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 05 | Day |
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
| 2022 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022102
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
