UMIN-CTR Clinical Trial

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