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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006626
Receipt No. 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

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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
Email 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
Email hiroki@surg1.med.tohoku.ac.jp

Sponsor
Institute Division of Hepato-Biliary Pancreatic Surgery
, Tohoku University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007840

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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