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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034650
Receipt No. 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

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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
Email 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
Email honnnori2003@yahoo.co.jp

Sponsor
Institute Higashiosaka City Medical Center
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
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039506

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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