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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000018744
Receipt No. R000021684
Scientific Title Study for the relationship between lung volume and low attenuation area of the lung evaluated by 3D-CT and preoperative and predicted postoperative pulmonary functions.
Date of disclosure of the study information 2015/08/20
Last modified on 2020/03/11

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Basic information
Public title Study for the relationship between lung volume and low attenuation area of the lung evaluated by 3D-CT and preoperative and predicted postoperative pulmonary functions.
Acronym Study for the relationship between lung volume and low attenuation area of the lung evaluated by 3D-CT and preoperative and predicted postoperative pulmonary functions.
Scientific Title Study for the relationship between lung volume and low attenuation area of the lung evaluated by 3D-CT and preoperative and predicted postoperative pulmonary functions.
Scientific Title:Acronym Study for the relationship between lung volume and low attenuation area of the lung evaluated by 3D-CT and preoperative and predicted postoperative pulmonary functions.
Region
Japan

Condition
Condition COPD, Lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology Chest surgery
Laboratory medicine Rehabilitation medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to reveal the differentiation between 1) actual values examined after lobectomy, 2) estimated postoperative values calculated with traditional methods (i.e.number of segments method) that does not consider the low attenuation area (LAA) of lung, and 3) resected lobular volume including its LAA obtained by 3D-CT on pulmonary function (i.e. FEV1) for lung cancer patients with and without COPD.
Basic objectives2 Others
Basic objectives -Others To reveal the differentiation between 1) actual values obtained after lobectomy, 2) estimated postoperative values calculated with traditional methods (i.e.number of segments method) that does not consider the LAA of lung, and 3) resected lobular volume including its LAA obtained by 3D-CT on pulmonary function (i.e. FEV1).
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Lung volume and LAA of the lung evaluated by 3D-CT, FEV1, FEV1/FVC, %FEV1, %DLco
Key secondary outcomes mMRC, score of COPD assessment test

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Pulmonaru function tests (VC and FVC maneuver) will be performed preoperative and 3, 6, and 12 months after lung surgery.
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 Lung cancer patients who performed lobectomy or pneumonectomy.
Key exclusion criteria Lung cancer patients who performed lung partial resection.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Masanori
Middle name
Last name Yokoba
Organization School of Allied Health Sciences, Kitasato University/Kitasato University Hospital
Division name Medical Laboratory Sciences/ Pulmonary Medicine
Zip code 194-0001
Address Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa, Japan
TEL 042-778-8111
Email myoko@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Masanori
Middle name
Last name Yokoba
Organization School of Allied Health Sciences, Kitasato University/ Kitasato University Hospital
Division name Medical Laboratory Sciences/ Pulmonary Medicine
Zip code 194-0001
Address Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa, Japan
TEL 042-778-8111
Homepage URL
Email myoko@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization none

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

IRB Contact (For public release)
Organization Kitasato University Medical Ethics Organization
Address Kitasato 1-15-1, Minami-ku, Sagamihara, Kanagawa, Japan
Tel 042-778-7756
Email rinri@med.kitasato-u.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

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 20 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 57
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 Main results already published
Date of protocol fixation
2013 Year 06 Month 28 Day
Date of IRB
2013 Year 06 Month 28 Day
Anticipated trial start date
2013 Year 11 Month 17 Day
Last follow-up date
2023 Year 11 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 20 Day
Last modified on
2020 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021684

Research Plan
Registered date File name
2020/03/11 LAAと術前後肺機能_研究実施計画書.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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