UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006190 |
|---|---|
| Receipt number | R000007324 |
| Scientific Title | Observational study of HER2 positive rate in advanced or recurrent gastric cancer |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2020/02/25 15:33:07 |
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Basic information
Public title
Observational study of HER2 positive rate in advanced or recurrent gastric cancer
Acronym
Observational study of HER2 positive rate in advanced or recurrent gastric cancer (JFMC44-1101)
Scientific Title
Observational study of HER2 positive rate in advanced or recurrent gastric cancer
Scientific Title:Acronym
Observational study of HER2 positive rate in advanced or recurrent gastric cancer (JFMC44-1101)
Region
| Japan |
Condition
Condition
Advanced or recurrent gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the HER2-positive rate and relationship between HER2-positive and various background factors in advanced or recurrent gastric cancer.
Basic objectives2
Others
Basic objectives -Others
Observation study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) HER2-positive rate.
2) Relation among HER2-positive, HER2- negative, patient background factors, and specimen background factors.
3) Relation among HER2 Status, patient background factors, and specimen background factors.
4) Relation among overall survival, patient background factors, and treatment background factors.
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
1) Histologically confirmed as being adenocarcinoma.
2) First diagnosed as advanced or recurrent gastric cancer since August, 2011.
3) Pathological tissue specimens and clinical information can be offered outside.
4) At least six thin sliced section (4 micron meter/slice) can be offered.
5) Written informed consent.
6) Age: 20 years or older
Key exclusion criteria
All patients who does not meet the key inclusion criteria
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Yoshida |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Surgical Oncology,Division of Tumor Control
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu 501-1194, Japan
TEL
058-230-6235
kyoshida@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Kawamura |
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Division name
Office
Zip code
136-0071
Address
1-28-6 kameido, koutou-ku, Tokyo, 136-0071, Japan
TEL
03-5627-7594
Homepage URL
http://www.jfmc.or.jp/
jfmc-dc@jfmc.or.jp
Sponsor or person
Institute
Japanese Foundation for Multidisciplinary Treatment of Cancer
Institute
Department
Personal name
Funding Source
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Address
1-28-6 kameido, koutou-ku, Tokyo, 136-0071, Japan
Tel
03-5627-7594
jfmc-dc@jfmc.or.jp
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 | 09 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Continuous prospective surveillance of HER2-positive rate and relationship between HER2-positive and various background factors.
Management information
Registered date
| 2011 | Year | 08 | Month | 18 | Day |
Last modified on
| 2020 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007324
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
