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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027152
Receipt No. R000031115
Scientific Title Efficacy and safety of edoxaban for lower-extremity venous thrombosis in patients with lung cancer - Prospective observational study-
Date of disclosure of the study information 2017/04/26
Last modified on 2022/10/29

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Basic information
Public title Efficacy and safety of edoxaban for lower-extremity venous thrombosis in patients with lung cancer - Prospective observational study-
Acronym Efficacy and safety of edoxaban for lower-extremity venous thrombosis in patients with lung cancer - Prospective observational study-
Scientific Title Efficacy and safety of edoxaban for lower-extremity venous thrombosis in patients with lung cancer - Prospective observational study-
Scientific Title:Acronym Efficacy and safety of edoxaban for lower-extremity venous thrombosis in patients with lung cancer - Prospective observational study-
Region
Japan

Condition
Condition lung cancer associated lower-extremity venous thrombosis
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficasy and safety of edoxaban for lung cancer associated lower-extremity venous thrombosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reduction of thrombus(2, 8, 16 weeks)
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) lung cancer patients with image-diagnosed lower-extremity deep vein thrombosis
(2) patients scheduled to begin treatment with edoxaban
(3) written informed consent
Key exclusion criteria (1) treatment with thrombectomy or thrombolytic therapy
(2) Inappropriate patients in this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kageaki
Middle name
Last name Taima
Organization Hirosaki University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code 036-8562
Address Zaifu-cho 5, Hirosaki, Japan
TEL +81-172-33-5111
Email taima0305@hotmail.com

Public contact
Name of contact person
1st name Kageaki
Middle name
Last name Taima
Organization Hirosaki University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code 036-8562
Address Zaifu-cho 5, Hirosaki, Japan
TEL +81-172-33-5111
Homepage URL
Email taima0305@hotmail.com

Sponsor
Institute Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Hirosaki University Graduate School of Medicine
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 Hirosaki University Graduate School of Medicine
Address Zaifu-cho 5, Hirosaki, Japan
Tel +81-172-33-5111
Email rinri@hirosaki-u.ac.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
2017 Year 04 Month 26 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
2015 Year 04 Month 27 Day
Date of IRB
2015 Year 07 Month 13 Day
Anticipated trial start date
2017 Year 04 Month 26 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (1) rate of increased thrombus in all periods (ultrasonography)
(2) recurrence of symptomatic venous thromboembolism in all periods
(3) The incidence of major bleeding or clinically significant bleeding in all periods
(4) All deaths in all periods
(5) blood test

Management information
Registered date
2017 Year 04 Month 26 Day
Last modified on
2022 Year 10 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031115

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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