UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006392
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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/
Email cspor-office@csp.or.jp

Sponsor
Institute "Cross-sectional study of 1st line treatment for metastatic colorectal cancer" Executive committee
Institute
Department

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
Email 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
URL(English) https://upload.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


Contact us.