UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on HER2 expression in metastatic colorectal cancer
Title of the study (Brief title)	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	Wataru Ichikawa
Organization	Showa University Fujigaoka Hospital
Division name	Division of Medical Oncology and Palliative Medicine
Address	1-30 Fujigaoka, Aoba-ku, Yokohama-shi, Kanagawa 224-8503, Japan
TEL	045-971-1151
Email	wataru@med.showa-u.ac.jp

Public contact
Name of contact person	Masashi Fujii
Organization	Japan Clinical Cancer Research Organization
Division name	Office
Address	7F, 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL	03-5579-9882
Homepage URL
Email	cc15.dc@jaccro.or.jp

Sponsor
Institute	Japan Clinical Cancer Research Organization
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021731