UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research for clinical validation of HER2 protein overexpression and gene amplification assay for salivary gland carcinoma
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Satoshi Kano
Organization	Hokkaido University Hospital
Division name	Otolaryngology-Head and Neck Surgery
Address	Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL	011-706-5958
Email	skano@med.hokudai.ac.jp

Public contact
Name of contact person	Satoshi Kano
Organization	Hokkaido University Hospital
Division name	Otolaryngology-Head and Neck Surgery
Address	Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido
TEL	011-706-5958
Homepage URL
Email	skano@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	This study showed a high overall concordance rate between 4B5 and HercepTest, between DISH and FISH, and between their combination assays.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018562