UMIN-CTR Clinical Trial

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	Completed
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	2020 Year 10 Month 13 Day

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