UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022606 |
|---|---|
| Receipt number | R000026058 |
| Scientific Title | Clinical usefulness of serum Mac-2 binding protein glycosylation isomer (M2BPGi) as a novel biomarker in respiratory diseases |
| Date of disclosure of the study information | 2016/06/04 |
| Last modified on | 2020/12/07 13:00:44 |
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Basic information
Public title
Clinical usefulness of serum Mac-2 binding protein glycosylation isomer (M2BPGi) as a novel biomarker in respiratory diseases
Acronym
Serum M2BPGi in respiratory diseases
Scientific Title
Clinical usefulness of serum Mac-2 binding protein glycosylation isomer (M2BPGi) as a novel biomarker in respiratory diseases
Scientific Title:Acronym
Serum M2BPGi in respiratory diseases
Region
| Japan |
Condition
Condition
Respiratory diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate usefulness of serum M2BPGi as a novel biomarker for respiratory diseases, such as asthma, COPD and interstitial pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of serum M2BPGi level between respiratory diseases (e.g. asthma, COPD, interstitial pneumonia) and normal control
Key secondary outcomes
To investigate correlation between serum M2BPGi and clinical characteristics, pulmonary function tests, FeNO, Chest HRCT findings in respiratory diseases.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
serum M2BPGi
pulmonary function test
FeNO
Chest HRCT
Impedance by forced oscillation technique (FOT)
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
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with respiratory diseases such as asthma, COPD and interstitial pneumonia
Key exclusion criteria
Patients who are unable to get informed consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Fujisawa |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
Address
1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan
TEL
053-435-2263
Homepage URL
fujisawa@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Address
Tel
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
| 2016 | Year | 06 | Month | 04 | 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
| 2015 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 04 | Day |
Last modified on
| 2020 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026058
