UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018786 |
|---|---|
| Receipt number | R000021731 |
| Scientific Title | Research on HER2 expression in metastatic colorectal cancer |
| Date of disclosure of the study information | 2015/08/25 |
| Last modified on | 2018/04/02 09:08:37 |
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Basic information
Public title
Research on HER2 expression in metastatic colorectal cancer
Acronym
HER2 expression MRC (JACCRO VV-15)
Scientific Title
Research on HER2 expression in metastatic colorectal cancer
Scientific Title:Acronym
HER2 expression MRC (JACCRO VV-15)
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the HER2 expression with immunohistochemistry(IHC), fluorescence in situ hybridization(FISH) and HERmark method using the existing tumor tissue paraffin-embedded specimen which identified a RAS genotype
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The HER2-positive ratio by the IHC method, the FISH method and the HERmark method
Key secondary outcomes
To evaluate the sensitivity of the HERmark method.
To examine the relationship between the HER2 expression and the background factor.
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
(1) Metastatic colorectal cancer.
(2) In the case of advanced colorectal cancer.
1-1) Case of StageIV resected the primary lesion.
1-2) RAS genetic-tested or KRAS genetic-tested using a tumor tissue paraffin-embedded block of the primary lesion.
i) RAS mutant-type or KRAS mutant-type
ii) RAS wild-type
In the case of recurrence colorectal cancer.
2-1) Case of StageI-III resected the primary lesion within 2 years.
2-2) The recurrence was confirmed after primary lesion excision.
2-3) RAS genetic-tested or KRAS genetic-tested using a tumor tissue paraffin-embedded block of the primary lesion.
i) RAS mutant-type or KRAS mutant-type
ii) RAS wild-type
(3) Patients who can provide a tumor tissue paraffin-embedded block of the primary lesion.
(4) Written informed consent.
Key exclusion criteria
(1) Patients who received neoadjuvant chemotherapy .
(2) Patients who are regarded as inadequate for study enrollment by investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wataru Ichikawa |
Organization
Showa University Fujigaoka Hospital
Division name
Division of Medical Oncology and Palliative Medicine
Zip code
Address
1-30 Fujigaoka, Aoba-ku, Yokohama-shi, Kanagawa 224-8503, Japan
TEL
045-971-1151
wataru@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Fujii |
Organization
Japan Clinical Cancer Research Organization
Division name
Office
Zip code
Address
7F, 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL
03-5579-9882
Homepage URL
cc15.dc@jaccro.or.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 08 | Month | 25 | 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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Recruit from institutions of JACCRO
To evaluate the HER2 expression with immunohistochemistry(IHC), fluorescence in situ hybridization(FISH) and HERmark method using the existing tumor tissue paraffin-embedded specimen which identified an RAS genotype.
Management information
Registered date
| 2015 | Year | 08 | Month | 24 | Day |
Last modified on
| 2018 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021731
