UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006626 |
|---|---|
| Receipt number | R000007840 |
| Scientific Title | Evaluation of KRAS and BRAF mutation rate in cholangiocarcinoma |
| Date of disclosure of the study information | 2011/10/28 |
| Last modified on | 2017/05/01 17:13:55 |
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Basic information
Public title
Evaluation of KRAS and BRAF mutation rate in cholangiocarcinoma
Acronym
Evaluation of KRAS and BRAF mutation rate in cholangiocarcinoma
Scientific Title
Evaluation of KRAS and BRAF mutation rate in cholangiocarcinoma
Scientific Title:Acronym
Evaluation of KRAS and BRAF mutation rate in cholangiocarcinoma
Region
| Japan |
Condition
Condition
cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the mutation rate of KRAS and BRAF in cholangiocarcinoma
Basic objectives2
Others
Basic objectives -Others
Observation study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mutation rate of KRAS and BRAF
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
1) Histologically confirmed as being adenocarcinoma of biliary tract.
2) Operation or biopsy was performed in Tohoku University Hospital.
3) enough sliced section (4 micron meter/slice) can be offered for this study.
4) Age: 20 years or older at operation or biopsy
Key exclusion criteria
All patients who does not meet the key inclusion criteria above.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiorki Hayashi |
Organization
Tohoku University Hospital
Division name
Hepato-Biliary Pancreatic Surgery
Zip code
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7205
hiroki@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Hayashi |
Organization
Tohoku University Hospital
Division name
Hepato-Biliary Pancreatic Surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7205
Homepage URL
hiroki@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Division of Hepato-Biliary Pancreatic Surgery
, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 28 | 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
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
Evaluate the KRAS and BRAF mutation rate and relationship between KRAS/BRAF mutation rate and various background factors.
Management information
Registered date
| 2011 | Year | 10 | Month | 28 | Day |
Last modified on
| 2017 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007840
| 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 |
