UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006392 |
|---|---|
| Receipt number | R000007567 |
| Scientific Title | pooled analysis of outcomes from 1st line treatment for metastatic colorectal cancer |
| Date of disclosure of the study information | 2011/09/22 |
| Last modified on | 2020/04/01 12:02:57 |
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Basic information
Public title
pooled analysis of outcomes from 1st line treatment for metastatic colorectal cancer
Acronym
Evaluation of first-line treatment for Metastatic colorectal cancer, Especially Resection of liver metastasis and Long survival, in Japanese Database.(EMERaLD)
Scientific Title
pooled analysis of outcomes from 1st line treatment for metastatic colorectal cancer
Scientific Title:Acronym
Evaluation of first-line treatment for Metastatic colorectal cancer, Especially Resection of liver metastasis and Long survival, in Japanese Database.(EMERaLD)
Region
| Japan |
Condition
Condition
metastatic colorectal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To collect and combine outcomes from clinical studies and to evaluate efficacy and safety, especially liver resection rate of first line treatment for metastatic colorectal cancer
To explore predictive factors for liver resection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival, liver resection rate, R0 liver resection rate
Key secondary outcomes
Response rate, Progression free survival, Safety, sub-group analysis (regimen specific, Kras status specific, etc)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) With first line treatment including oxaliplatin and bevacizumab for metastatic colorectal canncer
2)Treatment-Initiated after January, 2010
3) Radiologically assessed during first line treatment
4) Monitored by laboratory test and symptom check during first line treatment
5)able to provide observation data to this study
Key exclusion criteria
reservation
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Ohashi |
Organization
Chuo University, Tokyo
Division name
Department of Integraded Science and Technology,
Zip code
112-8551
Address
1-13-27 Kasuga, Bunkyo-ku, Tokyo JAPAN
TEL
03-3817-7280
no@csp.or.jp
Public contact
Name of contact person
| 1st name | Akita |
| Middle name | |
| Last name | Yamao |
Organization
Public Health Research Foundation
Division name
Comprehensive Support Project for Clinical Research
Zip code
169-0051
Address
1-1-7, Nishiwaseda, Shinjuku-ku, Tokyo, 169-0051, Japan
TEL
03-5287-2636
Homepage URL
http://www.csp.or.jp/
cspor-office@csp.or.jp
Sponsor or person
Institute
"Cross-sectional study of 1st line treatment for metastatic colorectal cancer" Executive committee
Institute
Department
Personal name
Funding Source
Organization
Public Health Research Foundation
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
PHRF IRB
Address
1-1-7, Nishiwaseda, Shinjuku-ku, Tokyo, 169-0051, Japan
Tel
03-5287-2636
cspor-office@csp.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 | 22 | Day |
Related information
URL releasing protocol
no
Publication of results
Unpublished
Result
URL related to results and publications
no
Number of participants that the trial has enrolled
1348
Results
no
Results date posted
| 2019 | Year | 10 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
no
Participant flow
no
Adverse events
no
Outcome measures
no
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2010 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2011 | Year | 09 | Month | 22 | Day |
Last modified on
| 2020 | 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=R000007567
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
