UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036697 |
|---|---|
| Receipt number | 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 | 2022/11/13 22:54:41 |
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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
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
aohba@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041814
