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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013186
Receipt No. R000015372
Scientific Title Multicenter study of serum HER2 monitoring in tissue HER2 positive gastric cancer
Date of disclosure of the study information 2014/02/18
Last modified on 2014/02/18

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Basic information
Public title Multicenter study of serum HER2 monitoring in tissue HER2 positive gastric cancer
Acronym Evaluation of serum HER2 in tissue HER2 positive gastric cancer
Scientific Title Multicenter study of serum HER2 monitoring in tissue HER2 positive gastric cancer
Scientific Title:Acronym Evaluation of serum HER2 in tissue HER2 positive gastric cancer
Region
Japan

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

Objectives
Narrative objectives1 To examine the relationship between the clinical response to treatment and the change of serum HER2 level
Basic objectives2 Others
Basic objectives -Others Comparison of the level of serum HER2 and the other tumor marker
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between the change of serum HER2 and clinical response to treatment
Key secondary outcomes Comparison of the level of serum HER2 and the other tumor marker

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 diagnosed HER2-positive gastric cancer
2.Patients with evaluable lesions
3.Patients before the treatment for gastric cancer
Key exclusion criteria 1. Patients with other active cancers
2. Patients with uncontrolled or severe complications
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sachio Fushida
Organization Kanazawa University
Digestive Disease Support Organization (DDSO)
Division name Gastroenterologic Surgery
Zip code
Address 13-1, Takara-machi, Kanazawa, Ishikawa 920-8641, Japan
TEL 076-265-2000
Email oya-ma@staff.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsunobu Oyama
Organization Kanazawa University
Division name Gastroenterologic Surgery
Zip code
Address 13-1, Takara-machi, Kanazawa, Ishikawa 920-8641, Japan
TEL 076-265-2000
Homepage URL
Email oya-ma@staff.kanazawa-u.ac.jp

Sponsor
Institute Gastroenterologic Surgery, Kanazawa University
Institute
Department

Funding Source
Organization Digestive Disease Support Organization (DDSO)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 02 Month 18 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 Enrolling by invitation
Date of protocol fixation
2014 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Monitoring of serum HER2 in HER2-positive gastric cancer

Management information
Registered date
2014 Year 02 Month 18 Day
Last modified on
2014 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015372

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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