UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033658 |
|---|---|
| Receipt number | R000038371 |
| Scientific Title | Drug Use-Results Survey of Erbitux (Injection 100 mg) for EGFR-Positive, Curatively Unresectable Advanced or Recurrent Colorectal Cancer Patients |
| Date of disclosure of the study information | 2018/08/08 |
| Last modified on | 2018/08/07 13:18:33 |
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Basic information
Public title
Drug Use-Results Survey of Erbitux (Injection 100 mg) for EGFR-Positive, Curatively Unresectable Advanced or Recurrent Colorectal Cancer Patients
Acronym
Drug Use-Results Survey of Erbitux (mCRC)
Scientific Title
Drug Use-Results Survey of Erbitux (Injection 100 mg) for EGFR-Positive, Curatively Unresectable Advanced or Recurrent Colorectal Cancer Patients
Scientific Title:Acronym
Drug Use-Results Survey of Erbitux (mCRC)
Region
| Japan |
Condition
Condition
EGFR-Positive, Curatively Unresectable Advanced or Recurrent Colorectal Cancer
Classification by specialty
| Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to detect unlisted adverse drug reactions (ADRs) of Erbitux (especially clinically significant ADR), to obtain the ADR profile of the product in clinical practice, and to identify any factor that affects the safety and effectiveness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
(Safety)
1-1. Profile of ADRs/infections reported (types, grades, and incidence rates, etc.)
1-2. Factors potentially affecting the safety of Erbitux (analyzing the types and incidence rates of ADRs/infections by patient demographic and baseline characteristics)
Key secondary outcomes
(Effectiveness)
1. Factors potentially affecting the effectiveness of Erbitux (analyzing the effective rate by patient demographic and baseline characteristics)
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
All patients who were administrated Erbitux for patient with EGFR-Positive, Curatively Unresectable Advanced or Recurrent Colorectal Cancer (mCRC).
Key exclusion criteria
Patients who do not give a full consent to this survey.
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Kameyama |
Organization
Merck Serono Co., Ltd.
Division name
PMS Planning & Strategy, Medical Department
Zip code
Address
Arco Tower 4F, 1-8-1, Shimomeguro, Meguro-ku, Tokyo, Japan
TEL
03-6756-0743
satoshi.kameyama@merckgroup.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Suzuka |
Organization
Merck Serono Co., Ltd.
Division name
PMS Planning & Strategy, Medical Department
Zip code
Address
Arco Tower 4F, 1-8-1, Shimomeguro, Meguro-ku, Tokyo, Japan
TEL
03-6756-0837
Homepage URL
hiroshi.suzuka@merckgroup.com
Sponsor or person
Institute
Merck Serono Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Merck Serono Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2018 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2008 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 26 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 26 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 30 | Day |
Other
Other related information
All-case survey
Management information
Registered date
| 2018 | Year | 08 | Month | 07 | Day |
Last modified on
| 2018 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038371
