UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034650 |
|---|---|
| Receipt number | R000039506 |
| Scientific Title | QOL assessment for pulmonary resection surgery |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2018/11/08 23:24:29 |
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Basic information
Public title
QOL assessment for pulmonary resection surgery
Acronym
QOL assessment for pulmonary resection surgery
Scientific Title
QOL assessment for pulmonary resection surgery
Scientific Title:Acronym
QOL assessment for pulmonary resection surgery
Region
| Japan |
Condition
Condition
pulmonary resection sugery
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of QOL tests in predicting the development of postoperative complications for pulmonary resection surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Utility of QOL tests in predicting the development of postoperative complications for pulmonary resection surgery
Key secondary outcomes
Utility of preoperative intervention in preventing the development of postoperative complications for pulmonary resection surgery
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
The patients who undergoing pulmonary resections at Higashiosaka City Medical Center
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nojiri |
Organization
Higashiosaka City Medical Center
Division name
General Thoracic Surgery
Zip code
Address
3-4-5, Nishi-iwata Higashiosaka-City
TEL
06-6781-5101
honnnori2003@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nojiri |
Organization
Higashiosaka City Medical Center
Division name
General Thoracic Surgery
Zip code
Address
3-4-5, Nishi-iwata Higashiosaka-City
TEL
06-6781-5101
Homepage URL
honnnori2003@yahoo.co.jp
Sponsor or person
Institute
Higashiosaka City Medical Center
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
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
| 2018 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 10 | 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
None
Management information
Registered date
| 2018 | Year | 10 | Month | 25 | Day |
Last modified on
| 2018 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039506
