UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041453 |
|---|---|
| Receipt number | R000047322 |
| Scientific Title | Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors: a systematic review and meta-analysis. |
| Date of disclosure of the study information | 2020/08/18 |
| Last modified on | 2021/02/17 10:30:50 |
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Basic information
Public title
Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors: a systematic review and meta-analysis.
Acronym
Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors: a systematic review and meta-analysis.
Scientific Title
Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors: a systematic review and meta-analysis.
Scientific Title:Acronym
Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors: a systematic review and meta-analysis.
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
tumors
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
category fo adverse event
Key secondary outcomes
frequency of adverse event
Base
Study type
Others,meta-analysis etc
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
treated with dabrafenib and trametinib
Key exclusion criteria
Without frequency or category of adverse event
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kou |
| Middle name | |
| Last name | Chin |
Organization
Yokohama city university
Division name
pulmonology
Zip code
2360004
Address
3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan
TEL
045-352-7962
chinksmd@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kou |
| Middle name | |
| Last name | Chin |
Organization
Yokohama city university
Division name
Pulomonology
Zip code
2360004
Address
3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan
TEL
045-352-7962
Homepage URL
chinksmd@yahoo.co.jp
Sponsor or person
Institute
3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan
Institute
Department
Personal name
Funding Source
Organization
3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama city university
Address
3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan
Tel
045-352-7962
chinksmd@yahoo.co.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
| 2020 | Year | 08 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 08 | Month | 18 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047322
