UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016033 |
|---|---|
| Receipt number | R000018640 |
| Scientific Title | Relationship EUS-elastography findings and some fobrotic proteins |
| Date of disclosure of the study information | 2014/12/22 |
| Last modified on | 2023/06/29 13:09:29 |
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Basic information
Public title
Relationship EUS-elastography findings and some fobrotic proteins
Acronym
EUS-elastograohy and SPARC
Scientific Title
Relationship EUS-elastography findings and some fobrotic proteins
Scientific Title:Acronym
EUS-elastograohy and SPARC
Region
| Japan |
Condition
Condition
locally advanced pancreas cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to define the relationship pre-operative EUS-elastographic findings and post-operative immunohistochemistry findings
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship the classification of EUS-elastographic findings and immunohistochemical finidings of the pancreas cancer.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The relationship EUS-elastographic findings and immunohistochemical findings
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
EUS-elastography is performed as pre-operative imaging finidings.
Surgical resection could be performed and immunohistochemical examination could be performed this specimes.
Key exclusion criteria
pre-operative chemotheraphy and/or chemoradiotheraphy cases.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Noritoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Yokohama City University Hospital
Division name
Medical Oncology
Zip code
2360004
Address
3-9, Fuku-ura, Kanazawa-ku, Yokohama
TEL
+81457872623
norikoba@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Noritoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Yokohama City University Hospital
Division name
Medical Oncology
Zip code
2360004
Address
3-9, Fuku-ura, Kanazawa-ku, Yokohama
TEL
+81457872623
Homepage URL
norikoba@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
Medical Oncology Division
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
Yokohama City University Hospital
Address
Yokohama City Kanazawa Ward Fukuura 3-9
Tel
+81457872623
norikoba@yokohama-cu.ac.jp
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
| 2014 | Year | 12 | Month | 22 | 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
| 2014 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
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 | 22 | Day |
Last modified on
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018640
