UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017528 |
|---|---|
| Receipt number | 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 18:56:11 |
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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)
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
blackcats921@yahoo.co.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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)
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020290
