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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020194
Receipt No. R000023322
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
Date of disclosure of the study information 2016/01/31
Last modified on 2019/09/28

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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
Middle name
Last name Takeshi Isobe
Organization Shimane University Faculty of Medicine
Division name Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
Zip code
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
Middle name
Last name Yukari Tsubata
Organization Shimane University Faculty of Medicine
Division name Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine
Zip code
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
Address
Tel
Email

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 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 No longer recruiting
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
2019 Year 09 Month 28 Day


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

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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