UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020194 |
|---|---|
| Receipt number | 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 | 2022/06/19 09:11:47 |
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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 | 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
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
ytsubata@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023322
