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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029661
Receipt No. R000033363
Scientific Title Imaging biomarker of acute exacerbation of interstitial pneumonia after surgical resection of lung cancer
Date of disclosure of the study information 2017/10/26
Last modified on 2019/04/25

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Basic information
Public title Imaging biomarker of acute exacerbation of interstitial pneumonia after surgical resection of lung cancer
Acronym Imaging biomarker of AE of IP after resection of lung cancer
Scientific Title Imaging biomarker of acute exacerbation of interstitial pneumonia after surgical resection of lung cancer
Scientific Title:Acronym Imaging biomarker of AE of IP after resection of lung cancer
Region
Japan

Condition
Condition Patients with lung cancer and interstitial pneumonia
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to determine imaging biomarker for the acute exacerbation in patients with lung cancer and interstitial pneumonia after surgical resection .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Correlation of acute exacerbation of interstitial pneumonia (IP) with the following; pattern of IP, degree of IP, degree of emphysema, diameter of the pulmonary trunk, lung volume
Key secondary outcomes Correlation of acute exacerbation of IP with the extent of honeycomb, ground glass opacity, consolidation, and blood chemistry study, pulmonary function test, the surgical procedure, preoperative medicine use

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) the patients aged 20 years and over
2) the patients who underwent HRCT within 30 days before the resection of lung cancer
Key exclusion criteria The patients whom the doctor in attendance judged to be unsuitable as a subject of the examination
Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Ozawa
Organization Nagoya City University
Division name Graduate School of Medical Sciences, Department of Radiology
Zip code
Address 1 kawasumi, mizuho-cho, mizuho-ku, Nagoya, Japan
TEL 0528538276
Email yoshioza@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Nakayasu
Organization Kondo photo process co.
Division name medical section
Zip code
Address 11-15, shimizudani-cho, tennnouji-ku, osaka, Japan
TEL 06-4303-4913
Homepage URL
Email uu-360@rinsho-kenkyu.org

Sponsor
Institute Department of Radiology, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Bayer
Organization
Division
Category of Funding Organization Outside Japan
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
2017 Year 10 Month 26 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 No longer recruiting
Date of protocol fixation
2017 Year 08 Month 15 Day
Date of IRB
2017 Year 08 Month 15 Day
Anticipated trial start date
2017 Year 08 Month 15 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Under the evaluation of images at multi-institutional collaboration study

Management information
Registered date
2017 Year 10 Month 22 Day
Last modified on
2019 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033363

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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