UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of KRAS and BRAF mutation rate in cholangiocarcinoma
Title of the study (Brief title)	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	Hiorki Hayashi
Organization	Tohoku University Hospital
Division name	Hepato-Biliary Pancreatic Surgery
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	Hiroki Hayashi
Organization	Tohoku University Hospital
Division name	Hepato-Biliary Pancreatic Surgery
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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