UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015960 |
|---|---|
| Receipt number | R000018562 |
| Scientific Title | Research for clinical validation of HER2 protein overexpression and gene amplification assay for salivary gland carcinoma |
| Date of disclosure of the study information | 2014/12/17 |
| Last modified on | 2016/07/25 08:02:49 |
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Basic information
Public title
Research for clinical validation of HER2 protein overexpression and gene amplification assay for salivary gland carcinoma
Acronym
Clinical validation of HER2 assay for salivary gland carcinoma
Scientific Title
Research for clinical validation of HER2 protein overexpression and gene amplification assay for salivary gland carcinoma
Scientific Title:Acronym
Clinical validation of HER2 assay for salivary gland carcinoma
Region
| Japan |
Condition
Condition
Salivary gland carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Development of companion diagnostics of HER2 for salivary gland carcinoma
Basic objectives2
Others
Basic objectives -Others
Conformity of HER2 positivity between each assay
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance rate of HER2 positivity between each assay
Key secondary outcomes
･Concordance rate of staining score between each immunohistochemistry
･Correlation of HER2/CEP17 ratio between FISH and DISH
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
･Treatment at Hokkaido University Hospital from January 1989 to September 2014
･Diagnosis of salivary gland carcinoma
Key exclusion criteria
No tissue specimen for assay
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Kano |
Organization
Hokkaido University Hospital
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5958
skano@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Kano |
Organization
Hokkaido University Hospital
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5958
Homepage URL
skano@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Clinical trials core hospitals maintenance business
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 17 | 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
This study showed a high overall concordance rate between 4B5 and HercepTest, between DISH and FISH, and between their combination assays.
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
| 2014 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
As basic research for development of companion diagnostics, we study clinical validation of immunohistochemistry and ISH assay about HER2 for salivary gland carcinoma
Management information
Registered date
| 2014 | Year | 12 | Month | 15 | Day |
Last modified on
| 2016 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018562
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
