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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006190
Receipt No. R000007324
Scientific Title Observational study of HER2 positive rate in advanced or recurrent gastric cancer
Date of disclosure of the study information 2011/09/01
Last modified on 2020/02/25

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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/ctr_e/ctr_view.cgi?recptno=R000007324

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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