UMIN-CTR Clinical Trial

Basic information
Public title	An observational study for incidence of thromboembolism in lung cancer patients, and the evaluation for efficacy and safety of edoxaban in active cancer patients with venous thromboembolism
Acronym	An observational study for incidence of thromboembolism in lung cancer patients
Scientific Title	An observational study for incidence of thromboembolism in lung cancer patients, and the evaluation for efficacy and safety of edoxaban in active cancer patients with venous thromboembolism
Scientific Title:Acronym	An observational study for incidence of thromboembolism in lung cancer patients
Region	Japan

Condition
Condition	Non-small cell lung cancer, small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the frequency of venous thromboembolism in lung cancer patient. To evaluate the efficacy and safety of edoxaban in lung cancer patient with VTE.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Frequency of symptomatic and asymptomatic VTE
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	edoxaban 60 or 30mg/day for 6 months
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	Pathologically or cytologically diagnosed non-small-cell or small cell lung cancer. ECOG PS 0-3 Age over 20 years old. Small cell lung cancer of ED-stage Non-small-cell lung cancer of stage IIIB or IV Reccurence of operation or concurrent chemoradiotherapy Best supportive care patient 2 months or longer expected survival. Written informed consent.
Key exclusion criteria	History of allergic reaction for edoxavan Severe renal dysfunction (Ccr under 30 mL/min) Severe liver disease Interstitial pneumonia Plannning for concurrent chemoradiotherapy Started medication or treatment for VTE Active bleeding Severe hypertention A pregnant woman, a woman in breast-feeding Taking aspirin or two kind os antiplatelet drug Acute infectious endocarditis An inappropriate case judged by doctor in charge
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Isobe
Organization	Shimane University Faculty of Medicine
Division name	Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
Zip code	693-8501
Address	89-1 Enya-cho, Izumo, Shimane
TEL	0853-20-2580
Email	isobeti@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Yukari Middle name Last name Tsubata
Organization	Shimane University Faculty of Medicine
Division name	Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
Zip code	693-8501
Address	89-1 Enya-cho, Izumo, Shimane
TEL	0853-20-2580
Homepage URL
Email	ytsubata@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization	Daiichi Sankyo
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address	Enya-cho 89-1, Izumo, Shimane
Tel	0853202580
Email	kenkyu@med.shimane-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	島根大学医学部附属病院、県立広島病院、広島赤十字・原爆病院、呉医療センター・中国がんセンター、高知大学医学部附属病院、広島大学病院、広島市立安佐市民病院、国立病院機構高知病院、国立病院機構三重医療センター、市立三次病院

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1025
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	Main results already published
Date of protocol fixation	2016 Year 02 Month 29 Day
Date of IRB	2016 Year 01 Month 13 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2021 Year 08 Month 13 Day
Date of closure to data entry	2021 Year 09 Month 30 Day
Date trial data considered complete	2021 Year 12 Month 31 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 12 Month 14 Day
Last modified on	2022 Year 06 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023322