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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030064
Receipt No. R000034325
Scientific Title HER2 screening study for metastatic colorectal cancer (additional studies of GI-SCREEN 2013-01-CRC)
Date of disclosure of the study information 2017/11/22
Last modified on 2019/05/24

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Basic information
Public title HER2 screening study for metastatic colorectal cancer (additional studies of GI-SCREEN 2013-01-CRC)
Acronym HER2 screening study
Scientific Title HER2 screening study for metastatic colorectal cancer (additional studies of GI-SCREEN 2013-01-CRC)
Scientific Title:Acronym HER2 screening study
Region
Japan

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

Objectives
Narrative objectives1 Detection of HER2 positive colorectal cancer
Basic objectives2 Others
Basic objectives -Others Screening of candidates to register to clinical trial
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of HER2 positive colorectal cancer
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)Patients with histologically confirmed metatstatic colorectal cancer.

2)Written informed consent was obtained.

3)Patients who have available FFPE blocks for HER2 examination and filled below condition i) or ii).

i)HER2 copy number was 4.0 and more in analysis with Oncomine Cancer Research Panel (OCP)or Oncomine Comprehensive Assay (OCA) in GI-screen 2013-01-CRC.

ii)Patient is judged by the investigator to be appropriate for study participation.
Key exclusion criteria none
Target sample size 120

Research contact person
Name of lead principal investigator
1st name YOSHIAKI
Middle name
Last name NAKAMURA
Organization National Cancer Center Hospital East
Division name Clinical Research Support Division
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 81-47-133-111
Email yoshinak@east.ncc.go.jp

Public contact
Name of contact person
1st name KENTARO
Middle name
Last name SAWADA
Organization National Cancer Center Hospital East
Division name Gastrointestinal Oncology Division
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL 81-47-133-111
Homepage URL
Email gi-screen-jimukyoku@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
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 National Cancer Center Hospital Instistutional Review Borad
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
Tel 81-47-133-1111
Email irst@ml.res.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
2017 Year 11 Month 22 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
2017 Year 11 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Relationship between HER2 status and other clinicopathological feature.

Management information
Registered date
2017 Year 11 Month 21 Day
Last modified on
2019 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034325

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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