UMIN-CTR Clinical Trial

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
Email	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
Email	j.nugroho.eko@fk.unair.ac.id

Sponsor
Institute	Dr. Soetomo General Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046041