UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029019 |
|---|---|
| Receipt number | 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 | 2020/10/13 09:55:40 |
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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
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
jm-ktakamatsu@kochi-u.ac.jp
Sponsor or person
Institute
kochi Medical School, Kochi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033126
