臨床研究等提出・公開システム

Date of registration	Sept. 20, 2016
Last modified on	April. 28, 2022
Trial ID	jRCT1080223325

Scientific Title	Multi-center collaborative research to investigate the expression of FGFR2 and HER2 proteins in gastric, gastroesophageal junction, and colorectal cancers
Public Title	DS-Screen

Completion Date or Terminated date	Aug. 20, 2018
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	DAIICHI SANKYO Co.,Ltd.
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	DAIICHI SANKYO Co.,Ltd.
	Address
	Phone Number
	E-mail Address	dsclinicaltrial@daiichisankyo.co.jp

Recruitment Status	completed

Date of First Enrolment		Nov. 21, 2016
Target Sample Size		700
Study Type		Observational
Study Design	Study Design	Observational study
Study Design	Objective	other
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	1. Agree with ICF 20 years and older 2. Patients who are histopathologically confirmed gastric, gastroesophageal junction or colorectal cancer, and applicable for chemotherapy 3.Suppliable unstained tumor tissue slide
	Exclusion Criteria	Not appropriate to this study judged by investigator or related
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Gastric, gastroesophageal junction and colorectal cancers
Intervention(s)		investigational material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : - control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		exploratory FGFR2 and HER2 protein expression IHC
Secondary Outcome		-

Primary Sponsor	DAIICHI SANKYO Co.,Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name	-
Address	1-4-9 Itachibori, Nishi-ku, Osaka-shi, Osaka 550-0012
Phone Number	+81-6-4393-8403
E-mail Address	osaka@sct-net.org
Status of Review	Approval
Date of Approval	Aug. 25, 2016

Secondary ID No.	JapicCTI-163380
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
13	April. 28, 2022	(this page)	Changes
12	May. 12, 2021	Detail	Changes
11	Sept. 15, 2020	Detail	Changes
10	Sept. 26, 2019	Detail	Changes
9	Dec. 17, 2018	Detail	Changes
8	July. 25, 2018	Detail	Changes
7	July. 25, 2018	Detail	Changes
6	April. 20, 2018	Detail	Changes
5	April. 20, 2018	Detail	Changes
4	Oct. 12, 2017	Detail	Changes
3	Oct. 12, 2017	Detail	Changes
2	Sept. 20, 2016	Detail	Changes
1	Sept. 20, 2016	Detail

List of change history