UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039751 |
|---|---|
| Receipt number | 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 21:26:37 |
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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
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
yoshinak@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045337
