UMIN-CTR Clinical Trial

Basic information
Public title	Observational study of HER2 positive rate in advanced or recurrent gastric cancer
Acronym	Observational study of HER2 positive rate in advanced or recurrent gastric cancer (JFMC44-1101)
Scientific Title	Observational study of HER2 positive rate in advanced or recurrent gastric cancer
Scientific Title:Acronym	Observational study of HER2 positive rate in advanced or recurrent gastric cancer (JFMC44-1101)
Region	Japan

Condition
Condition	Advanced or recurrent gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the HER2-positive rate and relationship between HER2-positive and various background factors in advanced or recurrent gastric cancer.
Basic objectives2	Others
Basic objectives -Others	Observation study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) HER2-positive rate. 2) Relation among HER2-positive, HER2- negative, patient background factors, and specimen background factors. 3) Relation among HER2 Status, patient background factors, and specimen background factors. 4) Relation among overall survival, patient background factors, and treatment background factors.
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically confirmed as being adenocarcinoma. 2) First diagnosed as advanced or recurrent gastric cancer since August, 2011. 3) Pathological tissue specimens and clinical information can be offered outside. 4) At least six thin sliced section (4 micron meter/slice) can be offered. 5) Written informed consent. 6) Age: 20 years or older
Key exclusion criteria	All patients who does not meet the key inclusion criteria
Target sample size	1200

Research contact person
Name of lead principal investigator	1st name Kazuhiro Middle name Last name Yoshida
Organization	Gifu University Graduate School of Medicine
Division name	Department of Surgical Oncology,Division of Tumor Control
Zip code	501-1194
Address	1-1 Yanagido, Gifu City, Gifu 501-1194, Japan
TEL	058-230-6235
Email	kyoshida@gifu-u.ac.jp

Public contact
Name of contact person	1st name Yukari Middle name Last name Kawamura
Organization	Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name	Office
Zip code	136-0071
Address	1-28-6 kameido, koutou-ku, Tokyo, 136-0071, Japan
TEL	03-5627-7594
Homepage URL	http://www.jfmc.or.jp/
Email	jfmc-dc@jfmc.or.jp

Sponsor
Institute	Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department

Funding Source
Organization	Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japanese Foundation for Multidisciplinary Treatment of Cancer
Address	1-28-6 kameido, koutou-ku, Tokyo, 136-0071, Japan
Tel	03-5627-7594
Email	jfmc-dc@jfmc.or.jp

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	2011 Year 09 Month 01 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	No longer recruiting
Date of protocol fixation	2011 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date	2011 Year 09 Month 01 Day
Last follow-up date	2015 Year 06 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Continuous prospective surveillance of HER2-positive rate and relationship between HER2-positive and various background factors.

Management information
Registered date	2011 Year 08 Month 18 Day
Last modified on	2020 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007324