UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040346 |
|---|---|
| Receipt number | R000046041 |
| Scientific Title | FACTOR Xa INHIBITORS FOR VENOUS THROMBOEMBOLISM MANAGEMENT IN PATIENT WITH CANCER |
| Date of disclosure of the study information | 2020/06/12 |
| Last modified on | 2020/05/09 17:12:23 |
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Basic information
Public title
FACTOR Xa INHIBITORS FOR VENOUS THROMBOEMBOLISM MANAGEMENT IN PATIENT WITH CANCER: A META-ANALYSIS
Acronym
FACTOR Xa INHIBITORS FOR VENOUS THROMBOEMBOLISM MANAGEMENT IN PATIENT WITH CANCER
Scientific Title
FACTOR Xa INHIBITORS FOR VENOUS THROMBOEMBOLISM MANAGEMENT IN PATIENT WITH CANCER
Scientific Title:Acronym
FACTOR Xa INHIBITORS FOR VTE MANAGEMENT IN CANCER: A META-ANALYSIS
Region
| Asia(except Japan) |
Condition
Condition
In Cancer patients with VTE or risk of VTE
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Since more randomized clinical trials (RCTs) are becoming available, we chose to perform a meta-analysis of randomized trials to assess the effectiveness of factor Xa inhibitor for venous thromboembolism management in patients with cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the recurrent VTE or VTE events rates and major bleeding incidence
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
any randomised controlled trials in which patients with a history of cancer or active cancer were allocated to receive an oral factor Xa inhibitor in one arm of treatment for the either treatment or prophylaxis of VTE
Key exclusion criteria
All phase II trials, trials involving anti-platelet in control arm of treatment, trials using anticoagulant as post-procedure prophylaxis of VTE
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Johanes |
| Middle name | |
| Last name | Nugroho |
Organization
Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Airlangga, Dr. Soetomo General Hospital, Surabaya
Division name
Department of Cardiology and Vascular Medicine
Zip code
60131
Address
Jl. Mayjen Prof. Dr. Moestopo 47
TEL
+6282139090953
j.nugroho.eko@fk.unair.ac.id
Public contact
Name of contact person
| 1st name | Johanes |
| Middle name | |
| Last name | Nugroho |
Organization
Department of Cardiology and Vascular Medicine, Faculty of Medicine Universitas Airlangga, Dr. Soeto
Division name
Department of Cardiology and Vascular Medicine
Zip code
60131
Address
Jl. Mayjen Prof. Dr. Moestopo 47
TEL
+6282139090953
Homepage URL
j.nugroho.eko@fk.unair.ac.id
Sponsor or person
Institute
Dr. Soetomo General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Komite Etik Penelitian Kesehatan RSUD Dr Soetomo Surabaya
Address
Jalan Mayjen. Prof. Dr. Moestopo No. 6-8, Surabaya, Jawa Timur 60286
Tel
+62315501011
kontak@rsudrsoetomo.jatimprov.go.id
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 | 06 | Month | 12 | 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
2000
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
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a meta-analysis of any RCTs
Management information
Registered date
| 2020 | Year | 05 | Month | 09 | Day |
Last modified on
| 2020 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046041
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
