UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023611 |
|---|---|
| Receipt number | R000026351 |
| Scientific Title | MUC4 is a new diagnostic marker for diffuse alveolar damage |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2023/05/15 21:44:13 |
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Basic information
Public title
MUC4 is a new diagnostic marker for diffuse alveolar damage
Acronym
Diagnostic Vlaue of MUC4
Scientific Title
MUC4 is a new diagnostic marker for diffuse alveolar damage
Scientific Title:Acronym
Diagnostic Vlaue of MUC4
Region
| Japan |
Condition
Condition
Diffuse Alveolar Damage
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To verify the usefulness of serum MUC4 for the diagnosis of diffuse alveolar damage.
Basic objectives2
Others
Basic objectives -Others
To estimate a correlation between serum MUC4 and severity of neutrophic inflammation of the lungs
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A correlation between serum MUC4 and severity of neutrophic inflammation of the lungs in patients with diffuse alevolar damage
Key secondary outcomes
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with difuse alveolar damage, suchas acute respiratory distress syndrome, lung drug injury, and acute excervation of interstitial pneumonia.
As a control group, patients with other pulmonary disease such as, bacterial pneumonia and srcoidosis, and healthy adults.
Key exclusion criteria
People who we can not get their consent on paper.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Ohta |
Organization
Saitama Medical Center Jichi Medical University
Division name
Department of Respiratory Medicine
Zip code
330-8503
Address
Tenuma 1-847, Oomiya-KU, Saitama
TEL
048-647-2111
hirooota4793@gmail.com
Public contact
Name of contact person
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Ohta |
Organization
Saitama Medical Center Jichi Medical University
Division name
Department of Respiratory Medicine
Zip code
330-8503
Address
Aminuma 1-847, Oomiya-KU, Saitama
TEL
048-647-2111
Homepage URL
hoota@jichi.ac.jp
Sponsor or person
Institute
Saitama Medical Center Jichi Medical University, Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center Jichi Medical University, Department of Respiratory 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
Saitama Medical Center Jichi Medical University
Address
Amanuma 1-847, Oomiya-KU, Saitama
Tel
048-647-2111
rinri@jichi.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
自治医科大学附属さいたま医療センター
Other administrative information
Date of disclosure of the study information
| 2016 | 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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To observe whether serum MUC4 of patients with diffuse alveolar damage is elevated.
Management information
Registered date
| 2016 | Year | 08 | Month | 12 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026351
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/05/15 | MUC４血清プロトコール自治.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
