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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029019
Receipt No. R000033126
Scientific Title Efficacy of Leucine rich alfa2 glycoprotein (LRG) as a biomarker in patients with diffuse lung disease
Date of disclosure of the study information 2017/10/01
Last modified on 2019/09/10

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Basic information
Public title Efficacy of Leucine rich alfa2 glycoprotein (LRG) as a biomarker in patients with diffuse lung disease
Acronym Efficacy of Leucine rich alfa2 glycoprotein (LRG) in patients with diffuse lung disease
Scientific Title Efficacy of Leucine rich alfa2 glycoprotein (LRG) as a biomarker in patients with diffuse lung disease
Scientific Title:Acronym Efficacy of Leucine rich alfa2 glycoprotein (LRG) in patients with diffuse lung disease
Region
Japan

Condition
Condition Diffuse lung disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Currently, serum KL - 6 and CRP are measured in diffuse lung diseases in order to evaluate the inflammation and activity of disease condition. However, there are patients whose KL-6 has a normal value despite high activity. Therefore, in the early stage of acute exacerbation, we also experiences cases that KL-6 do not become biomarker. Previous studies have suggested that leucine rich alpha 2 glycoprotein (LRG) may rise in diffuse lung disease, but the meaning as diagnostic marker, therapeutic marker, therapeutic effect predictive marker, prognosis predictive marker is unknown. We aim to clarify the clinical meaning of LRG using serum and bronchoalveolar lavage fluid (BAL) of patients with diffuse lung disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Whether LRG become the biomarker for disease differentiation and activity of disease
Key secondary outcomes Whether LRG become the biomarker for effect of treatment and prediction of prognosis

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 patients with diffuse lung disease
Key exclusion criteria Cases that can not cooperate with the examination conducted in this study
Cases with other respiratory diseases such as lung cancer and non-tuberculous mycobacteria
Cases in which consent has not been obtained for this research
Case judged by the attending physician to be unqualified
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Ohnishi
Organization kochi Medical School, Kochi University
Division name Department of Hematology and Respiratory Medicine
Zip code 7838480
Address Oko-cho, Kohasu, Nankoku, Kochi, 783-8505, Japan
TEL 088-880-2345
Email honi@kochi-u.ac.jp

Public contact
Name of contact person
1st name Kazufumi
Middle name
Last name Takamatsu
Organization kochi Medical School, Kochi University
Division name Department of Hematology and Respiratory Medicine
Zip code 7838480
Address Oko-cho, Kohasu, Nankoku, Kochi, 783-8505, Japan
TEL 088-880-2345
Homepage URL
Email jm-ktakamatsu@kochi-u.ac.jp

Sponsor
Institute kochi Medical School, Kochi University
Institute
Department

Funding Source
Organization no funding source
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 kochi university ethic comittee
Address oko-cho kohasu nankoku
Tel 0888665811
Email rinri21@kochi-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
2017 Year 10 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
2017 Year 08 Month 15 Day
Date of IRB
2017 Year 09 Month 30 Day
Anticipated trial start date
2017 Year 10 Month 01 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 no other information

Management information
Registered date
2017 Year 09 Month 06 Day
Last modified on
2019 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033126

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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