UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027152
Receipt number 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 18:58:51

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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 or person

Institute

Hirosaki University Graduate School of Medicine

Institute

Department

Personal name



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

Value
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