UMIN-CTR Clinical Trial

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	300
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	Completed
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	2022 Year 11 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041814