UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013186 |
|---|---|
| Receipt number | 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 12:11:59 |
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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
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
oya-ma@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Gastroenterologic Surgery, Kanazawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015372
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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