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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036697
Receipt No. R000041814
Scientific Title A screening study of HER2 expression for biliary tract cancer
Date of disclosure of the study information 2019/05/09
Last modified on 2019/05/09

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Basic information
Public title A screening study of HER2 expression for biliary tract cancer
Acronym HERB preSCR
Scientific Title A screening study of HER2 expression for biliary tract cancer
Scientific Title:Acronym HERB preSCR
Region
Japan

Condition
Condition biliary tract cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To detect HER2 expressing biliary tract cancer using HER2 testing
Basic objectives2 Others
Basic objectives -Others Screening study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HER2 expression
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 proven adenocarcinoma or adenosquamous carcinoma
2. Unresectable or recurrent biliary tract cancer by chest computed tomography (CT) and enhanced abdominal/pelvic CT or magnetic resonance imaging (MRI).
3. Age, 20 years or elder.
4. Written informed consent.
Key exclusion criteria None
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Chigusa
Middle name
Last name Morizane
Organization National Cancer Center Hospital
Division name Department of Hepatobiliary and Pancreatic Oncology
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Email cmorizan@ncc.go.jp

Public contact
Name of contact person
1st name Akihiro
Middle name
Last name Ohba
Organization National Cancer Center Hospital
Division name Department of Hepatobiliary and Pancreatic Oncology
Zip code 104-0045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email aohba@ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization NCC IRB
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Tel 03-3542-2511
Email irst@ncc.go.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
2019 Year 05 Month 09 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
2019 Year 03 Month 04 Day
Date of IRB
2019 Year 03 Month 13 Day
Anticipated trial start date
2019 Year 05 Month 09 Day
Last follow-up date
2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To detect HER2 expressing biliary tract cancer using HER2 testing.

Management information
Registered date
2019 Year 05 Month 09 Day
Last modified on
2019 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041814

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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