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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041800
Receipt No. R000045932
Scientific Title Quantitative and qualitative evaluation in residual lung after lung resection surgery
Date of disclosure of the study information 2020/09/17
Last modified on 2020/09/15

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Basic information
Public title Quantitative and qualitative evaluation in residual lung after lung resection surgery
Acronym Quantitative and qualitative evaluation in residual lung after lung resection surgery
Scientific Title Quantitative and qualitative evaluation in residual lung after lung resection surgery
Scientific Title:Acronym Quantitative and qualitative evaluation in residual lung after lung resection surgery
Region
Japan

Condition
Condition The patients who will undergo lung resection
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim is to detect the increase in the residual lung after lung resection, with using a reconstruction application on CT.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The volume of the residual lung after lung resection and the size and the number in the empysematous lung
Key secondary outcomes Results of spirometory

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 will undergo lung resection.
Key exclusion criteria The patients who had undergone lung resection and the patients who had and will have surgery for pneumothorax, lung abscess and thoracoplasty.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Junko
Middle name
Last name Nakahira
Organization Osaka Medical College
Division name Department of Anesthesiology
Zip code 569-8686
Address 3-5-7
TEL 09098748678
Email ane052@osaka-med.ac.jp

Public contact
Name of contact person
1st name Junko
Middle name Nakahira
Last name Nakahira
Organization Osaka Medical College
Division name Department of Anesthesiology
Zip code 569-8686
Address 2-7 DAIGAKU-MACHI
TEL 0726831221
Homepage URL
Email ane052@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research <KAKENHI>
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of Osaka Medical COllege
Address 2-7 DAIGAKU-MACHI
Tel +81726831221
Email rinri@osaka-med.ac.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 大阪医科大学附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 17 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
2020 Year 09 Month 01 Day
Date of IRB
2020 Year 09 Month 01 Day
Anticipated trial start date
2020 Year 09 Month 17 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
2024 Year 12 Month 31 Day
Date trial data considered complete
2024 Year 12 Month 31 Day
Date analysis concluded
2025 Year 08 Month 31 Day

Other
Other related information This is a prospective observational study. We need to get informed consent from all the patients who join in this study.

Management information
Registered date
2020 Year 09 Month 15 Day
Last modified on
2020 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045932

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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