UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016164 |
|---|---|
| Receipt number | R000018761 |
| Scientific Title | The prospective observational study for researching the association between the survivals and the amount of malignant pleural effusion in patients of malignant pleuritis |
| Date of disclosure of the study information | 2015/01/10 |
| Last modified on | 2018/07/12 11:37:03 |
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Basic information
Public title
The prospective observational study for researching the association between the survivals and the amount of malignant pleural effusion in patients of malignant pleuritis
Acronym
The observational study for researching the association between the survivals and the amount of malignant pleural effusion
Scientific Title
The prospective observational study for researching the association between the survivals and the amount of malignant pleural effusion in patients of malignant pleuritis
Scientific Title:Acronym
The observational study for researching the association between the survivals and the amount of malignant pleural effusion
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
researching the association between the survivals and the amount of malignant pleural effusion in patients of malignant pleuritis
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients with malignant pleulitis diagnosed pathologically or cytologically
2) patients with non-small cell lung cancer
Key exclusion criteria
1) patients with distant metastases
2) PS3 or 4
3) patients with heart or hepatic falure
4) patients with history of thoracotomy or hemorrhagic
5) patients with multiple cancers
6) patients with severe mental disorder
7) patients with severe thoracic adhesion
Target sample size
213
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohei Yokoi |
Organization
Nagoya university school of medicine
Division name
department of thoracic surgery and respiratory medicine
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2376
shota197065@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shota Nakamura |
Organization
Nagoya university
Division name
department of thoracic surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2376
Homepage URL
shota197065@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Funding Source
Organization
Nagoya university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
central japan lung study group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 01 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The depth is measured on CT as an amount of pleural effusion with patients with malignant pleuritis. and the patients were observed their survival.
Management information
Registered date
| 2015 | Year | 01 | Month | 08 | Day |
Last modified on
| 2018 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018761
