UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030064 |
|---|---|
| Receipt number | 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 | 2022/03/29 14:20:15 |
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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
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
gi-screen-jimukyoku@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
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
National Cancer Center Hospital Instistutional Review Borad
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
Tel
81-47-133-1111
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
147
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
| 2017 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034325
