UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006048 |
|---|---|
| Receipt number | 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 22:38:42 |
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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
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
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007156
