UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006451 |
|---|---|
| Receipt number | R000007657 |
| Scientific Title | Correlation between Prognosis and HER2 status in Advanced/Recurrent Gastric Cancer: Multicenter Retrospective Analysis |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2014/04/01 12:09:52 |
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Basic information
Public title
Correlation between Prognosis and HER2 status in Advanced/Recurrent Gastric Cancer: Multicenter Retrospective Analysis
Acronym
HER2 Gastric Cancer
Scientific Title
Correlation between Prognosis and HER2 status in Advanced/Recurrent Gastric Cancer: Multicenter Retrospective Analysis
Scientific Title:Acronym
HER2 Gastric Cancer
Region
| Japan |
Condition
Condition
Advanced/Recurrent Gastric Cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Explore correlation between prognosis and HER2 status in advanced/recurrent gastric cancer
Basic objectives2
Others
Basic objectives -Others
exploration
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
correlation between prognosis and HER2 status in advanced/recurrent gastric cancer
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
For 1), 2), 4) and 5), patients who meet the following criteria at the baseline of the first line chemotherapy
1) Histologically confirmed gastric or gastroesophageal junction adenocarcinoma
2) Unresectable advanced or recurrent cancer
3) Patients who received S-1 plus cisplatin as the first line chemotherapy during Jan, 2006 and Mar, 2010
4) Age >= 20
5) PS: 0-2 (ECOG performance status score)
6) Archived tumor material
Key exclusion criteria
1) Patients who refuse the use of clinical information and material for this study
2) Patients with active malignancy at the baseline of the first line chemotherapy
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nozomu Fuse |
Organization
National Cancer Center Hospital East
Division name
Gastrointestinal Oncology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Japan
TEL
04-7133-1111
nofuse@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nozomu Fuse |
Organization
National Cancer Center Hospital East
Division name
Gastrointestinal Oncology
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa-shi, Japan
TEL
04-7133-1111
Homepage URL
nofuse@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Gan Kenkyu Kaihatsuhi
Organization
Division
Category of Funding Organization
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 | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
Retrospective analysis
Management information
Registered date
| 2011 | Year | 10 | Month | 01 | Day |
Last modified on
| 2014 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007657
