UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009210 |
|---|---|
| Receipt number | R000010810 |
| Scientific Title | Immunohistochemical analysis of malignancy grade in patients with intrahepatic cholangiocarcinoma. |
| Date of disclosure of the study information | 2012/11/01 |
| Last modified on | 2012/10/29 12:23:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Immunohistochemical analysis of malignancy grade in patients with intrahepatic cholangiocarcinoma.
Acronym
Immunohistochemical analysis of malignancy grade in patients with intrahepatic cholangiocarcinoma.
Scientific Title
Immunohistochemical analysis of malignancy grade in patients with intrahepatic cholangiocarcinoma.
Scientific Title:Acronym
Immunohistochemical analysis of malignancy grade in patients with intrahepatic cholangiocarcinoma.
Region
| Japan |
Condition
Condition
Intrahepatic cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the malignancy and prognosis of intrahepatic cholangiocarcinoma with the use of immunostaining method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Expression frequency of EGFR,VEGF,HER2,Ki-67,CK8,CK18,CK7,CK19 etc.
Key secondary outcomes
Prognosis
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
Surgical cases with the diagnosis of intrahepatic cholangiocarcinoma
Key exclusion criteria
Below the age of 20.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryusei Matsuyama |
Organization
Yokohama City University Graduated school of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama-shi, Kanagawa prefecture
TEL
045-787-2650
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryusei Matsuyama |
Organization
Yokohama City University Graduated school of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama-shi, Kanagawa prefecture
TEL
045-787-2650
Homepage URL
Sponsor or person
Institute
Department of Gastroenterological Surgery, Yokohama City University Graduated school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery, Yokohama City University Graduated school of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | 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
We will evaluate the malignancy of surgical cases of intrahepatic cholangiocarcinoma by immunostaining methods using EGFR,VEGF,HER-2,Ki-67,CK8,CK18,CK7,CK19.
If it's needed, we will add the case of hepatocellularcarcinoma.
Management information
Registered date
| 2012 | Year | 10 | Month | 29 | Day |
Last modified on
| 2012 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010810
