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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039751
Receipt No. R000045337
Scientific Title A study for assessment of HER2 status using Gene-Protein Assay (GPA) in metastatic colorectal cancer
Date of disclosure of the study information 2020/03/10
Last modified on 2020/03/09

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Basic information
Public title A study for assessment of HER2 status using Gene-Protein Assay (GPA) in metastatic colorectal cancer
Acronym HER2 GPA study in mCRC
Scientific Title A study for assessment of HER2 status using Gene-Protein Assay (GPA) in metastatic colorectal cancer
Scientific Title:Acronym A study for assessment of HER2 status using Gene-Protein Assay (GPA) in metastatic colorectal cancer
Region
Japan North America

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess HER2 status by Gene-Protein Assay (GPA) in metastatic clorectal cancer
Basic objectives2 Others
Basic objectives -Others Performance evaluation of GPA
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A concordance of HER2 status assessment between GPA and IHC/FISH
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria A. the patients who is registered HER2 screening study and express a consent of secondary use of specimen.
Key exclusion criteria none
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Yoshiaki
Middle name
Last name Nakamura
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology and Gastrointestinal oncology
Zip code 2778577
Address 6-5-1, Kashiwanoha, Kashiwa-shi, Chiba, Japan
TEL +81-4-7133-1111
Email yoshinak@east.ncc.go.jp

Public contact
Name of contact person
1st name Yoshiaki
Middle name
Last name Nakamura
Organization National Cancer Center Hospital East
Division name Department of Gastroenterology and Gastrointestinal oncology
Zip code 2778577
Address 6-5-1, Kashiwanoha, Kashiwa-shi, Chiba, Japan
TEL +81-4-7133-1111
Homepage URL
Email yoshinak@east.ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization Self-procurement
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Cancer Center Hospital East
Address 6-5-1, Kashiwanoha, Kashiwa-shi, Chiba, Japan
Tel +81-4-7133-1111
Email yoshinak@east.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
2020 Year 03 Month 10 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 Enrolling by invitation
Date of protocol fixation
2019 Year 07 Month 31 Day
Date of IRB
2019 Year 09 Month 10 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information additional studies of HER2 screening study

Management information
Registered date
2020 Year 03 Month 09 Day
Last modified on
2020 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045337

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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