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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006048
Receipt No. R000007156
Scientific Title Interrelationship of Serum HER2-ECD with Pathological HER2 level (Human Epidermal Growth Factor Receptor Type2 - Extra Cellular Domain) in Operable Gastric Cancer Patients in Japan
Date of disclosure of the study information 2011/08/01
Last modified on 2011/09/22

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Basic information
Public title Interrelationship of Serum HER2-ECD with Pathological HER2 level (Human Epidermal Growth Factor Receptor Type2 - Extra Cellular Domain) in Operable Gastric Cancer Patients in Japan
Acronym sHER2-GC
Scientific Title Interrelationship of Serum HER2-ECD with Pathological HER2 level (Human Epidermal Growth Factor Receptor Type2 - Extra Cellular Domain) in Operable Gastric Cancer Patients in Japan
Scientific Title:Acronym sHER2-GC
Region
Japan

Condition
Condition Gastric Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We examine interrelationship of serum HER2-ECD with pathological HER2 level in operable gastric cancer patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Interrelationship of serum HER2-ECD with pathological HER2 level.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 We measure serum HER2-ECD by the Chemiluminescence immunoassay.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Histological proven gastric adenocarcinoma.
2)cStage IB/IIA/IIB/IIIA/IIIB/IIIC (except for T1)
3)Patient considered that R(0) resection is possible.
4)Age 20-80 years
5)ECOG PS: 0 or 1
6)No prior treatment
7)Adequate organ functions defined as indicated below
(1)WBC >= 2,500 /mm3
(2)Plt >= 100,000 /mm3
(3) T.Bil <= 2.0 mg/dL
(4) AST, ALT <= 100 IU/L
(5) Cr <= 1.5 mg/dL
8)Written informed consent
Key exclusion criteria 1) Patient with Breast cancer
2) Patient with active double cancer (synchronous double cancer and metachronous double cancer), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
3) Patient with severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis)
4) Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Takagi
Organization Shizuoka General Hospital
Division name Surgery
Zip code
Address 4-27-1 Kitaandou, Aoi-ku, Shizuokashi, Shizuoka 420-8527 Japan
TEL 054-247-6111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Keisei Taku
Organization Shizuoka General Hospital
Division name Medical Oncology
Zip code
Address 4-27-1 Kitaandou, Aoi-ku, Shizuokashi, Shizuoka 420-8527 Japan
TEL 054-247-6111
Homepage URL
Email

Sponsor
Institute Shizuoka General Hospital
Institute
Department

Funding Source
Organization Shizuoka Prefectural Hospital Organization
Organization
Division
Category of Funding Organization Non profit foundation
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
2011 Year 08 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 Open public recruiting
Date of protocol fixation
2011 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 07 Month 26 Day
Last modified on
2011 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007156

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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