UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035931 |
|---|---|
| Receipt number | R000040864 |
| Scientific Title | A Study of cardiovascular events in patients with lung cancer |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2020/03/03 09:04:54 |
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Basic information
Public title
A Study of cardiovascular events in patients with lung cancer
Acronym
Retrospective single center Observational Study of cardiovascular events in patients with lung cancer
Scientific Title
A Study of cardiovascular events in patients with lung cancer
Scientific Title:Acronym
Retrospective single center Observational Study of cardiovascular events in patients with lung cancer
Region
| Japan |
Condition
Condition
lung cancer, cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between Coronary Artery Calcium and cardiovascular events in patients with resected lung cancer
Basic objectives2
Others
Basic objectives -Others
To investigate the predictive value of Coronary Artery Calcium on adverse cardiac events in patients with resected lung cancer
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
major adverse cardiovascular events in patients with lung cancer
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This study population included patients with resected lung cancer at Okayama Red Cross General Hospital between2012 and 2018.
Key exclusion criteria
none
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Osawa |
Organization
Okayama Red Cross General Hospital
Division name
Department of Cardiovascular Medicine
Zip code
7008607
Address
2-1-1 Aoe, Kita-ku, Okayama city, Okayama, Japan
TEL
0862228811
kosawa@okayama-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Osawa |
Organization
Okayama Red Cross General Hospital
Division name
Department of Cardiovascular Medicine
Zip code
7008607
Address
2-1-1 Aoe, Kita-ku, Okayama city, Okayama, Japan
TEL
0862228811
Homepage URL
kosawa@okayama-med.jrc.or.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Okayama Red Cross General Hospital, Okayama, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Okayama Red Cross General Hospital, Okayama, Japan
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
Okayama Red Cross General Hospital, Okayama, Japan
Address
2-1-1 Aoe, Kita-ku, Okayama city, Okayama, Japan
Tel
0862228811
oka-rcgh@okayama-med.jrc.or.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
| 2019 | Year | 03 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study to see an association between cardiovascular events and coronary artery calcium in patients with resected lung cancer.
Management information
Registered date
| 2019 | Year | 02 | Month | 19 | Day |
Last modified on
| 2020 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040864
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
