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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017528
Receipt No. R000020290
Scientific Title Multicenter observational study to investigate incidence of pulmonary venous thrombosis and of cerebral infarction after radical surgery for lung cancer
Date of disclosure of the study information 2015/05/13
Last modified on 2021/05/17

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Basic information
Public title Multicenter observational study to investigate incidence of pulmonary venous thrombosis and of cerebral infarction after radical surgery for lung cancer
Acronym Observational study for pulmonary venous thrombosis after lung cancer surgery
Scientific Title Multicenter observational study to investigate incidence of pulmonary venous thrombosis and of cerebral infarction after radical surgery for lung cancer
Scientific Title:Acronym Observational study for pulmonary venous thrombosis after lung cancer surgery
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate incidence of pulmonary venous thrombosis and of cerebral infarction after radical surgery for lung cancer
Basic objectives2 Others
Basic objectives -Others observation
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of pulmonary venous thrombosis after surgery for lung cancer by method distinction
Key secondary outcomes Incidence of cerebral infarction

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.candidate of the lobectmy for the primary lung cancer
2.not ditected the pulmonary venous thrombosis on the enhanced CT before the operation
3.adult male and female 20 years and over
4.no past history of the cerebral infarction
5.informed consent
6.without atrium fiblliration
7.not received indution therapy
Key exclusion criteria 1.contrast media allergy
2.chronic renal failure eGFR under 45ml/min/1.73ml/min/m2
3.received indution therapy
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Yoshino
Organization Graduate School of Medicine, Chiba University
Division name Department of General Thoracic Surgery
Zip code 260-8677
Address 1-8-1, Inohana, Chuo-ku, Chiba
TEL 043-222-7171(ext.5464)
Email axxa1838@chiba-u.jp

Public contact
Name of contact person
1st name Takayoshi26
Middle name
Last name Yamamoto
Organization Graduate School of Medicine, Chiba University
Division name Department of General Thoracic Surgery
Zip code 260-8677
Address 1-8-1, Inohana, Chuo-ku, Chiba
TEL 043-222-7171(ext.5464)
Homepage URL
Email blackcats921@yahoo.co.jp

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics Committee, Chiba University
Address 1-8-1, Inohana, Chuo-ku, Chiba
Tel 043-221-7171(5461)
Email axxa1838@chiba-u.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
2015 Year 05 Month 13 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 490
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason In February 2021, we received a CRF for one year after the completion of new incorporation, and we are currently writing the paper.
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 Enrolling by invitation
Date of protocol fixation
2015 Year 05 Month 07 Day
Date of IRB
2015 Year 05 Month 07 Day
Anticipated trial start date
2015 Year 05 Month 13 Day
Last follow-up date
2020 Year 05 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study
thrombosis of pulmonary vein of the lobectomy dictinction

Management information
Registered date
2015 Year 05 Month 12 Day
Last modified on
2021 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020290

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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